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Regulatory Intelligence

Navigate the Regulatory Landscape and Make Smart Decisions

Stay current with ever-changing regulations, with routine updates from ClinChoice. Use the reference chart below to follow regulatory updates on a variety of medical topics from health authorities and countries worldwide. Have questions or want to talk to an expert? Contact us to schedule a consultation.


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Country/Region Health Authority Date of Publishing Product Type Topic Domain URL
USA Food and Drug Administration 8-5-24 Drug CDER Center for Clinical Trial Innovation (C3TI) Clinical Visit Page
Malaysia National Pharmaceutical Regulatory Agency 30-4-24 Drug Guideline for application of clinical trial import licence and clinical trial exemption Clinical Visit Page
Europe European Commission 25-4-24 Medical Device Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics Regulatory Visit Page
Australia Therapeutic Goods Administration 24-4-24 Drug Nitrosamine impurities acceptable intakes update Regulatory Visit Page
Europe European Commission 22-4-24 Medical Device Charting the path forward: Joint stakeholder statement on the implementation of the EHDS Regulatory Visit Page
The Philippines Philippines FDA 16-4-24 Drug Prescribing the Guidelines on Good Manufacturing Practice (GMP) for Drug Manufacturers Repealing AO No. 2013-0022 (draft for comments) Regulatory Visit Page
The Philippines Philippines FDA 15-4-24 Drug Clarification on the requirements for change of Qualified Person initially registered in a licensed drug establishment Regulatory Visit Page
International The Eurasian Economic Union 12-4-24 Drug Updates in uniform Rules for conducting bioequivalence studies of medicinal products Clinical Visit Page
International The Eurasian Economic Union 12-4-24 Drug Updates in the unified Rules for conducting pharmaceutical inspections of pharmacovigilance systems of drug manufacturers Pharmacovigilance Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 11-4-24 Medical Device Outcome of the consultation on standards for contraceptive devices in New Zealand Regulatory Visit Page
USA Food and Drug Administration 10-4-24 Drug CBER Rare Disease Program Clinical Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 9-4-24 Drug JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs Regulatory Visit Page
Japan Pharmaceuticals and Medical Devices Agency 8-4-24 Drug New drug review with electronic data Regulatory Visit Page
Malaysia National Pharmaceutical Regulatory Agency 8-4-24 Drug Malaysian guideline for Bioequivalence inspection 2nd edition (draft for comments) Clinical Visit Page
Brazil Brazilian Health Regulatory Agency 8-4-24 Medical Device ANVSIA will use assessment from foreign authorities to register medical devices Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 5-4-24 Drug Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 5-4-24 Drug UK Parallel Import Licences Following Agreement of the Windsor Framework Regulatory Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 4-4-24 Drug As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools Regulatory Visit Page
India Central Drugs Standard Control Organisation 3-4-24 Medical Device Strengthening of private medical devices testing laboratory in India Regulatory Visit Page
Ireland Health Products Regulatory Authority 3-4-24 Drug Submitting a Request for a New National Application Procedure for a Human Medicinal Product Regulatory Visit Page
Australia Therapeutic Goods Administration 2-4-24 Drug Updated guidelines for Assessed listed medicines Regulatory Visit Page
International World Health Organization 1-4-24 Drug WHO Good Manufacturing Practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products (draft for comments) Regulatory Visit Page
The Philippines Philippines FDA 1-4-24 Drug Guidelines on the Classification of Deficiencies Observed During Inspection of Drug Distributors, Drugstores, Hospital Pharmacies and Retail Outlet for Non-Prescription Drugs (RONPD) (draft for comments) Regulatory Visit Page
Europe European Commission 1-4-24 Medical Device Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 Safety Visit Page
Europe European Commission 1-4-24 Medical Device Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices Clinical Visit Page
Australia Therapeutic Goods Administration 1-4-24 Medical Device Consultation: Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (draft for comments) Regulatory Visit Page
Australia Therapeutic Goods Administration 1-4-24 Medical Device Instructions for Use for Medical Devices Consultation on availability of instructions for use in more flexible formats (draft for comments) Labeling Visit Page
USA Food and Drug Administration 1-4-24 Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers (draft for comments) Labeling Visit Page
USA Food and Drug Administration 1-4-24 Drug Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (draft for comments) Quality Visit Page
USA Food and Drug Administration 1-4-24 Drug Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies Safety Visit Page
USA Food and Drug Administration 1-4-24 Drug Providing Regulatory Submissions in Electronic Format: IND Safety Reports Regulatory Visit Page
USA Food and Drug Administration 29-3-24 Medical Device Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions Non-Clinical Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 28-3-24 Drug How CEP holders can avoid the rejection of notifications Regulatory Visit Page
Europe European Commission 28-3-24 Medical Device First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published Regulatory Visit Page
Europe European Medicines Agency 27-3-24 Drug European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure Regulatory Visit Page
Europe European Medicines Agency 25-3-24 Drug HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorization application (MAA) dossier (draft for comments) Quality Visit Page
Europe European Medicines Agency 25-3-24 Drug Guideline on quality, non-clinical and clinical requirements for investigational advanced Clinical Visit Page
Brazil Brazilian Health Regulatory Agency 22-3-24 Drug Anvisa extends the validity period of the Good Manufacturing Practices Certificate to four years Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 20-3-24 Drug Outcome of the consultation on the proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Pharmacovigilance Pharmacovigilance Visit Page
Europe European Commission 20-3-24 Drug Commission takes action to boost biotechnology and biomanufacturing in the EU Regulatory Visit Page
India Indian Pharmacopoeia Commission 18-3-24 Drug IPC signs Memorandum of Understanding with USP Regulatory Visit Page
Europe European Medicines Agency 16-3-24 Drug Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD) Clinical Visit Page
Australia Therapeutic Goods Administration 15-3-24 Medical Device Draft guidance: Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials and Investigator’s brochures for medical device clinical trials Clinical Visit Page
Australia Therapeutic Goods Administration 15-3-24 Medical Device Companion diagnostics guidance update- public consultation (draft for comments) Regulatory Visit Page
USA Food and Drug Administration 15-3-24 Drug Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 15-3-24 Medical Device Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling Regulatory Visit Page
Europe European Commission 14-3-24 Cosmetic MedTech Europe views on the ‘One Substance, One Assessment’ European Commission package of legislative proposals Regulatory Visit Page
Europe European Medicines Agency 13-3-24 Drug New Organization First User EU QPPV/RP or Change of EU QPPV/RP Pharmacovigilance Visit Page
USA Food and Drug Administration 13-3-24 Medical Device Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (draft guidance) Quality Visit Page
USA Food and Drug Administration 12-3-24 Medical Device Banned Devices; Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior Regulatory Visit Page
USA Food and Drug Administration 12-3-24 Drug Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act Regulatory Visit Page
USA Food and Drug Administration 12-3-24 Drug Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing; Guidance for Industry; Clinical Visit Page
Europe European Commission 11-3-24 Drug Commission proposes new measures for the better lifecycle management of medicine authorisations Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 11-3-24 Medical Device MHRA response to Equity in Medical Devices: Independent Review Regulatory Visit Page
Australia Therapeutic Goods Administration 7-3-24 Cosmetic Advertising health services Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 4-3-24 Drug Public consultation on ICH Guideline E2D(R1) launched in Switzerland Safety Visit Page
Europe European Commission 1-3-24 Medical Device Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices Clinical Visit Page
UK Medicines and Healthcare products Regulatory Agency 1-3-24 Drug Established medicines: marketing authorisation application changes Regulatory Visit Page
USA Food and Drug Administration 1-3-24 Drug Handling and Retention of BA and BE Testing Samples (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-3-24 Drug Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-3-24 Drug Controlled Correspondence Related to Generic Drug Development Regulatory Visit Page
USA Food and Drug Administration 1-3-24 Drug Controlled Correspondence Related to Generic Drug Development Regulatory Visit Page
USA Food and Drug Administration 1-3-24 Drug Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products (draft guidance) Labeling Visit Page
USA Food and Drug Administration 1-3-24 Drug Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry (draft guidance) Clinical Visit Page
USA Food and Drug Administration 1-3-24 Drug Q14 Analytical Procedure Development Regulatory Visit Page
USA Food and Drug Administration 1-3-24 Drug Q2(R2) Validation of Analytical Procedures Regulatory Visit Page
USA Food and Drug Administration 1-3-24 Drug Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards (draft for guidance) Clinical Visit Page
USA Food and Drug Administration 1-3-24 Medical Device Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 061 Regulatory Visit Page
USA Food and Drug Administration 28-2-24 Biologics Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics Regulatory Visit Page
Europe European Medicines Agency 12-2-24 Drug Guideline on the pharmaceutical quality of inhalation and nasal medicinal products Regulatory Visit Page
India Central Drugs Standard Control Organisation 2-2-24 Drug Post approval changes in biologics – Quality, safety and efficacy documents Regulatory Visit Page
USA Food and Drug Administration 1-2-24 Drug Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide Regulatory Visit Page
USA Food and Drug Administration 23-1-24 Medical Device Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff Regulatory Visit Page
Europe European Medicines Agency 23-1-24 Drug Innovation in medicines Regulatory Visit Page
Europe European Medicines Agency 15-1-24 Drug Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products Safety Visit Page
USA Food and Drug Administration 8-1-24 Drug SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA) Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 31-12-23 Drug Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework Labeling Visit Page
USA Food and Drug Administration 15-12-23 Drug SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications Clinical Visit Page
USA Food and Drug Administration 1-12-23 Drug Quality Considerations for Topical Ophthalmic Drug Products (draft guidance) Quality Visit Page
Europe European Commission 28-11-23 Medical Device COFEPRIS accepts GMP certificates issued by WHO accredited Health Authorities/PIC/S Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 20-11-23 Drug Interleukin inhibitors and the possible risk of pancreatitis Safety Visit Page
Australia Therapeutic Goods Administration 20-11-23 Drug New medicine adverse event search for sponsors Safety Visit Page
Mexico COFEPRIS 13-11-23 Drug Modifications to health registration conditions, regulatory simplification strategy Regulatory Visit Page
China National Medical Products Administration 9-11-23 Drug NMPA becomes the applicant for PIC/S Regulatory Visit Page
Ireland Health Products Regulatory Authority 9-11-23 Drug Outcome of the Process - Public Consultation on proposed fees for Human Medicines, Compliance, Medical Devices and Veterinary Medicines for 2024 Regulatory Visit Page
Brazil Brazilian Health Regulatory Agency 8-11-23 Drug ANMAT and ANVISA signed the first Mutual Recognition agreement on certificates for Medical Products Regulatory Visit Page
International International Council for Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use 8-11-23 Drug ICH adopts Q5A(R2) guideline on viral safety evaluation of biotechnology products and validation of analytical procedures Q2(R2) Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 6-11-23 Drug International Recognition Procedure Regulatory Visit Page
Europe European Commission 1-11-23 Medical Device Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements Regulatory Visit Page
Malaysia National Pharmaceutical Regulatory Agency 1-11-23 Drug Guideline for facilitated registration pathway Regulatory Visit Page
Japan Pharmaceuticals and Medical Devices Agency 1-11-23 Drug Pharmaceuticals and Medical Devices Safety Information No. 405 November 2023 Safety Visit Page
International World Health Organization 31-10-23 Drug Landmark listing of first three countries as WHO-Listed regulatory Authorities Regulatory Visit Page
USA Food and Drug Administration 27-10-23 Medical Device Good Machine Learning Practice for Medical Device Development: Guiding Principles Regulatory Visit Page
Europe European Medicines Agency 24-10-23 Drug EMA takes further steps to address critical shortages of medicines in the EU Regulatory Visit Page
USA Food and Drug Administration 24-10-23 Medical Device Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles Regulatory Visit Page
Europe European Commission 20-10-23 Medical Device Amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses Regulatory Visit Page
USA Food and Drug Administration 19-10-23 Drug Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 19-10-23 Medical Device Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring Regulatory Visit Page
USA Food and Drug Administration 18-10-23 Medical Device Team-NB asks manufacturers of class D devices to submit IVDR filings Regulatory Visit Page
Europe European Medicines Agency 12-10-23 Drug Guideline on the Development and Manufacture of Synthetic Peptides Regulatory Visit Page
USA Food and Drug Administration 10-10-23 Medical Device Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Regulatory Visit Page
USA Food and Drug Administration 10-10-23 Medical Device Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices Regulatory Visit Page
Europe European Commission 5-10-23 Drug Pharmacopoeial Discussion Group welcomes Indian Pharmacopoeia Commission as a member, facilitating reach and enhancing impact of pharmacopoeial standards harmonisation Regulatory Visit Page
USA Food and Drug Administration 3-10-23 Drug Filing Review of Abbreviated New Drug Applications Regulatory Visit Page
USA Food and Drug Administration 2-10-23 Drug Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Guidance for Industry (draft guidance) Clinical Visit Page
USA Food and Drug Administration 2-10-23 Drug Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 2-10-23 Drug Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol Regulatory Visit Page
USA Food and Drug Administration 2-10-23 Drug Diabetic Foot Infections: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
USA Food and Drug Administration 2-10-23 Drug Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention; Request for Comment and Informational Presentation Clinical Visit Page
USA Food and Drug Administration 2-10-23 Drug Stimulant Use Disorders: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
USA Food and Drug Administration 2-10-23 Drug Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Readyto-Use Containers — “Dose Banding” Labeling Visit Page
Europe European Medicines Agency 1-10-23 Drug Nitrosamine impurities Safety Visit Page
USA Food and Drug Administration 29-9-23 Medical Device Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology Regulatory Visit Page
USA Food and Drug Administration 29-9-23 Medical Device Electronic Submission Template for Medical Device De Novo Requests Publishing Visit Page
USA Food and Drug Administration 29-9-23 Medical Device Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling Labeling Visit Page
UK Medicines and Healthcare products Regulatory Agency 29-9-23 Drug Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework Labeling Visit Page
USA Food and Drug Administration 27-9-23 Medical Device Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Regulatory Visit Page
USA Food and Drug Administration 22-9-23 Medical Device Electronic Submission Template for Medical Device 510(k) Submissions Publishing Visit Page
Singapore Health Sciences Authority 21-9-23 Drug HSA is assessing the potential risk of suicidal thoughts and self-harm with glucagon-like peptide-1 receptor agonists (GLP-1 RA) Safety Visit Page
Europe European Commission 21-9-23 Medical Device Changes to the acceptability of CEP applications for sterile grade materials Regulatory Visit Page
Ireland Health Products Regulatory Authority 20-9-23 Drug Guide for National Scientific and Regulatory Advice Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 19-9-23 Medical Device The Innovative Devices Access Pathway (IDAP) Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 15-9-23 Drug Changes to the guidance document Temporary authorisation of human medicinal products Regulatory Visit Page
USA Food and Drug Administration 15-9-23 Medical Device Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations (draft guidance) Non-Clinical Visit Page
USA Food and Drug Administration 15-9-23 Medical Device Medical Devices with Indications 2 Associated with Weight Loss - Clinical 3 Study and Benefit-Risk Considerations (draft guidance) Clinical Visit Page
USA Food and Drug Administration 15-9-23 Drug Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments Regulatory Visit Page
Australia Therapeutic Goods Administration 11-9-23 Drug Post market responsibilities for manufacturers and sponsors of medical devices Pharmacovigilance Visit Page
USA Food and Drug Administration 11-9-23 Drug Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (draft guidance) Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 10-9-23 Drug Swiss GMDP database Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 4-9-23 Drug Processing of adverse reaction reports received in New Zealand Safety Visit Page
Colombia The National Institute of Drug and Food Surveillance 1-9-23 Drug Renewal of medicinal product approvals – No longer required Regulatory Visit Page
International International Medical Device Regulators Forum 1-9-23 Medical Device Personalized Medical Devices – Regulatory Pathways Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 1-9-23 Drug FAQs: General Pharmacovigilance Pharmacovigilance Visit Page
Australia Therapeutic Goods Administration 1-9-23 Drug Changes to the regulation of sports supplements in medicinal dosage forms Labeling Visit Page
Europe European Commission 1-9-23 Medical Device Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR Regulatory Visit Page
Europe European Medicines Agency 1-9-23 Biologics Questions and answers for biological medicinal products Regulatory Visit Page
Europe European Medicines Agency 1-9-23 Drug Guideline on clinical investigation of medicinal products in the treatment of depression Clinical Visit Page
Europe European Medicines Agency 1-9-23 Drug PRAC recommends new measures to avoid topiramate exposure in pregnancy Pharmacovigilance Visit Page
USA Food and Drug Administration 1-9-23 Medical Device Regulatory Considerations for Prescription Drug Use Related Software (draft guidance) Labeling Visit Page
USA Food and Drug Administration 1-9-23 Drug Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-9-23 Drug Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies Clinical Visit Page
USA Food and Drug Administration 1-9-23 Biologics Labeling for Biosimilar and Interchangeable Biosimilar Products Guidance for Industry (draft guidance) Labeling Visit Page
Europe European Commission 1-9-23 Medical Device Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Regulatory Visit Page
USA Food and Drug Administration 1-9-23 Drug Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment (draft guidance) Clinical Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 1-9-23 Drug Guidelines on the Regulation of Therapeutic Products in New Zealand Regulatory Visit Page
Australia Therapeutic Goods Administration 30-8-23 Drug Product Information inserts are no longer required for injectable medicines administered by health professionals Labeling Visit Page
USA Food and Drug Administration 29-8-23 Drug Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (draft guidance) Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 29-8-23 Medical Device Three new UK Approved Bodies to certify medical devices announced by the MHRA Regulatory Visit Page
Australia Therapeutic Goods Administration 25-8-23 Medical Device Feedback from Australian Sponsors about the Medical Device Single Audit Program (MDSAP) Regulatory Visit Page
Australia Therapeutic Goods Administration 24-8-23 Drug Nitrosamine impurities in medicines - Information for sponsors and manufacturers Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 24-8-23 Drug Nitrosamines impurities in medicines Regulatory Visit Page
Australia Therapeutic Goods Administration 17-8-23 Drug New reporting requirements for medicine shortages Regulatory Visit Page
Europe European Medicines Agency 16-8-23 Drug EMA review of data on paternal exposure to valproate Pharmacovigilance Visit Page
Europe European Medicines Agency 10-8-23 Medical Device TEAM-NB Position Paper New MDR Transition Timelines and Notified Body Capacity Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 9-8-23 Drug Swissmedic gains accreditation for GMP/GDP inspections in the field of ATMPs Regulatory Visit Page
Europe European Medicines Agency 7-8-23 Drug Guidance to applicants /Marketing Authorization Holders (MAHs) on oral explanations at EMA Regulatory Visit Page
USA Food and Drug Administration 2-8-23 Medical Device Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number Regulatory Visit Page
India Central Drugs Standard Control Organisation 1-8-23 Drug FAQS on implementation of GSR 823(e) dated 17th November, 2022 with respect to bar code or QR code on top 300 brands Visit Page
UK Medicines and Healthcare products Regulatory Agency 1-8-23 Medical Device CE marking recognition for medical devices and in vitro diagnostics Regulatory Visit Page
Malaysia Medical Device Authority 1-8-23 Medical Device Wearable medical device – Guidance document Regulatory Visit Page
Malaysia Medical Device Authority 1-8-23 Medical Device Importation of medical device for personal use Regulatory Visit Page
Japan Pharmaceuticals and Medical Devices Agency 1-8-23 Drug Points to be Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials Clinical Visit Page
Japan Pharmaceuticals and Medical Devices Agency 1-8-23 Drug Update on nitrosamine contamination Regulatory Visit Page
USA Food and Drug Administration 1-8-23 Drug Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act Labeling Visit Page
USA Food and Drug Administration 1-8-23 Drug Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR Regulatory Visit Page
USA Food and Drug Administration 1-8-23 Drug PDUFA Waivers, Reductions, and Refunds for FixedCombinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-8-23 Drug Classification Categories for Certain Supplements Under BsUFA III (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-8-23 Drug Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-8-23 Drug Post marketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products Clinical Visit Page
USA Food and Drug Administration 1-8-23 Drug Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors Clinical Visit Page
USA Food and Drug Administration 1-8-23 Drug Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 1-8-23 Medical Device CE marking recognition for medical devices and in vitro diagnostics Regulatory Visit Page
India Central Drugs Standard Control Organisation 1-8-23 Drug FAQS ON IMPLEMENTATION OF GSR 823(E) DATED 17TH NOVEMBER, 2022 WITH RESPECT TO BAR CODE OR QR CODE ON TOP 300 BRANDS Labeling Visit Page
The Philippines Philippines FDA 1-8-23 Drug Draft for Comments || Application Process and Requirements for Post-Approval Changes of Biological Products Adopting the World Health Organization Guidelines for Changes to Approved Vaccines and Biotherapeutic Products for Human Use Regulatory Visit Page
USA Food and Drug Administration 28-7-23 Medical Device Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder (draft guidance) Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 27-7-23 Drug MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect Regulatory Visit Page
USA Food and Drug Administration 27-7-23 Medical Device Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions Labeling Visit Page
Europe European Medicines Agency 26-7-23 Drug Questions and Answers (Q&As) on the External Guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use Clinical Visit Page
Europe European Commission 25-7-23 Drug Commission acts to accelerate phasing out of animal testing in response to a European Citizens' Initiative Non-Clinical Visit Page
USA Food and Drug Administration 24-7-23 Drug CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization Regulatory Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 24-7-23 Drug N-nitrosamine impurities in Ph. Eur. monographs: update on approach Regulatory Visit Page
Europe European Medicines Agency 20-7-23 Drug Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Regulatory Visit Page
USA Food and Drug Administration 17-7-23 Medical Device Qualification of Medical Device Development Tools Quality Visit Page
USA Food and Drug Administration 10-7-23 Medical Device Electronic Export Documents – Letter to Industry Regulatory Visit Page
USA Food and Drug Administration 10-7-23 Drug Post marketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (draft guidance) Clinical Visit Page
Europe European Commission 10-7-23 Medical Device Medical devices – single identifier for similar highly individualized devices Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 5-7-23 Drug Nitrosamine impurities in medicinal products: Swissmedic sets up specialist group Regulatory Visit Page
USA Food and Drug Administration 3-7-23 Biologics Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 3-7-23 Drug CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality Regulatory Visit Page
USA Food and Drug Administration 3-7-23 Drug Understanding CDER’s Risk-Based Site Selection Model Regulatory Visit Page
International World Health Organization 3-7-23 Drug WHO Guidance for best practices for clinical trials Draft for public consultation Clinical Visit Page
International World Health Organization 3-7-23 Drug Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability Regulatory Visit Page
International The International Council for Harmonisation 3-7-23 Drug International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines Regulatory Visit Page
The Philippines Philippines FDA 3-7-23 Drug Rules and Regulations on the Issuance of Authorization for Registration Applications of Drug Products and Drug Substances by the Food and Drug Administration (draft guidance) Regulatory Visit Page
Singapore Health Sciences Authority 3-7-23 Drug Public consultation on the proposed regulation for active ingredients under the health products act Regulatory Visit Page
USA Food and Drug Administration 29-6-23 Drug Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development (draft guidance) Clinical Visit Page
UK Medicines and Healthcare products Regulatory Agency 16-6-23 Medical Device Great Britain to accept European CE marks until June 2030 to ensure continued supply Regulatory Visit Page
Europe European Medicines Agency 31-5-23 Drug Progress with EU-US mutual recognition agreement for inspections for veterinary medicines Regulatory Visit Page
USA Food and Drug Administration 30-5-23 Medical Device FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 26-5-23 Medical Device New regulatory pathway set to support safe patient access to innovative medical technologies Regulatory Visit Page
Europe European Union 24-5-23 Medical Device Template for NB - Confirmation letter in the framework of Regulation (EU) 2023/607 Regulatory Visit Page
USA Food and Drug Administration 22-5-23 Medical Device Send and Track Medical Device Premarket Submissions Online: CDRH Portal Regulatory Visit Page
International International Council for Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use 19-5-23 Drug Good Clinical Practice (GCP) E6(R3) (draft guidance) Clinical Visit Page
Australia Therapeutic Goods Administration 17-5-23 Drug GMP Clearance: Extension processing times Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 15-5-23 Drug Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system Regulatory Visit Page
USA Food and Drug Administration 12-5-23 Medical Device Supply and Shortages of Medical Devices: Frequently Asked Questions Regulatory Visit Page
USA Food and Drug Administration 12-5-23 Medical Device Medical Device Supply Chain and Shortages Regulatory Visit Page
Australia Therapeutic Goods Administration 11-5-23 Drug New safety warning for medicines used in arthritis and other inflammatory conditions Safety Visit Page
USA Food and Drug Administration 11-5-23 Drug FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions Safety Visit Page
USA Food and Drug Administration 11-5-23 Drug Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products; Availability Regulatory Visit Page
Europe European Medicines Agency 10-5-23 Vaccine EMA and European medicines regulatory network lift COVID-19 business continuity status Regulatory Visit Page
Europe European Medicines Agency 8-5-23 Drug Commission guidance on the content and structure of the summary of the clinical investigation report Clinical Visit Page
The Philippines Philippines FDA 5-5-23 Drug Adoption of the World Health Organization Updated Guidelines on the Evaluation of Similar Biotherapeutic Products (SBPs) in Compliance with Administrative Order No. 2014-0016 Regulatory Visit Page
Australia Therapeutic Goods Administration 5-5-23 Medical Device EU MDR transition extension Regulatory Visit Page
USA Food and Drug Administration 4-5-23 Drug Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments Safety Visit Page
Australia Therapeutic Goods Administration 3-5-23 Drug TGA makes final decision to reduce paracetamol pack sizes Packaging Visit Page
Europe European Medicines Agency 3-5-23 Drug Interim guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.0 Clinical Visit Page
Europe European Medicines Agency 3-5-23 Drug Review of transparency rules for the EU Clinical Trials Information System (CTIS) Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 1-5-23 Drug Changes to the forms for new authorizations of and variations to human and veterinary medicinal products Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 1-5-23 Drug Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers Regulatory Visit Page
The Philippines Philippines FDA 1-5-23 Drug Guidelines for the Importation and Exportation of Finished Drug Products and Raw Materials (draft guidance) Regulatory Visit Page
Australia Therapeutic Goods Administration 1-5-23 Drug Antibiotics shortage update and substitution allowed to address shortage of Cefaclor Regulatory Visit Page
Europe European Medicines Agency 1-5-23 Drug Electronic product information (ePI) Labeling Visit Page
Europe European Union 1-5-23 Medical Device Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regards to devices covered by certificates according to MDD or AIMDD Regulatory Visit Page
USA Food and Drug Administration 1-5-23 Drug Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol Regulatory Visit Page
USA Food and Drug Administration 1-5-23 Drug Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products (draft guidance) Clinical Visit Page
USA Food and Drug Administration 1-5-23 Drug Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products Clinical Visit Page
USA Food and Drug Administration 1-5-23 Drug Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers Non-Clinical Visit Page
USA Food and Drug Administration 1-5-23 Drug Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information (draft guidance) Non-Clinical Visit Page
USA Food and Drug Administration 1-5-23 Drug Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act Regulatory Visit Page
USA Food and Drug Administration 1-5-23 Drug Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products Regulatory Visit Page
USA Food and Drug Administration 1-5-23 Drug Q9(R1) Quality Risk Management Quality Visit Page
USA Food and Drug Administration 1-5-23 Drug Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022 Regulatory Visit Page
USA Food and Drug Administration 1-5-23 Drug Decentralized Clinical Trials for Drugs, Biological Products, and Devices (draft guidance) Clinical Visit Page
USA Food and Drug Administration 1-5-23 Drug Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Clinical Visit Page
USA Food and Drug Administration 1-5-23 Drug S12 Nonclinical Biodistribution Considerations for Gene Therapy Products Safety Visit Page
Europe European Commission 27-4-23 Patents Intellectual property: harmonised EU patent rules boost innovation, investment, and competitiveness in the Single Market Intellectual property (IP) Visit Page
Europe European Medicines Agency 26-4-23 Drug Concept paper on revision of the guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome Clinical Visit Page
Europe European Medicines Agency 26-4-23 Drug Harmonized bioequivalence guideline paves the way for global generic medicine development and access to medicines Clinical Visit Page
Europe European Commission 26-4-23 Drug Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines Regulatory Visit Page
International World Health Organization 25-4-23 Drug Medical Product Alert N°4/2023: Substandard (contaminated) syrup medicines Safety Visit Page
USA Food and Drug Administration 24-4-23 Drug Product-Specific Guidance Meetings Between the Food and Drug Administration and Abbreviated New Drug Applicants Under the Generic Drug User Fee Act (draft guidance) Regulatory Visit Page
Europe European Medicines Agency 21-4-23 Drug Single-arm trials as pivotal evidence for the authorization of medicines in the EU Clinical Visit Page
Europe European Union 19-4-23 Medical Device Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745 Regulatory Visit Page
France French National Agency for the Safety of Medicines and Health Products 19-4-23 Drug data.ansm: An online platform to learn more about adverse drug reactions and stock-outs Safety Visit Page
USA Food and Drug Administration 19-4-23 Drug New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability Regulatory Visit Page
USA Food and Drug Administration 18-4-23 Vaccine Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines Regulatory Visit Page
Singapore Health Sciences Authority 17-4-23 Drug Industry consultation on Electronic Common Technical Document (eCTD) implementation in Singapore Regulatory Visit Page
USA Food and Drug Administration 14-4-23 Drug Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 13-4-23 Medical Device Announcements on clinical trials with medical devices and performance studies with vitro diagnostic medical devices Clinical Visit Page
USA Food and Drug Administration 13-4-23 Drug FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use Safety Visit Page
USA Food and Drug Administration 11-4-23 Drug EPA Proposes New Standards to Protect Public Health, Reduce Exposure to Ethylene Oxide Pollution Regulatory Visit Page
USA Food and Drug Administration 10-4-23 Drug Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 6-4-23 Medical Device Software and Artificial Intelligence (AI) as a Medical Device Regulatory Visit Page
Australia Therapeutic Goods Administration 5-4-23 Drug Dual labelled medicines begin transition to sole medicine ingredient names soon Labeling Visit Page
USA Environmental Protection Agency 4-4-23 Food & Food Supplement Publishes Tolerances for Deltamethrin on Various Agricultural Commodities Safety Visit Page
Europe European Medicines Agency 4-4-23 Drug New features further strengthen Priority Medicines scheme (PRIME) Regulatory Visit Page
International International Medical Device Regulators Forum 4-4-23 Medical Device Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form Pharmacovigilance Visit Page
Malaysia National Pharmaceutical Regulatory Agency 4-4-23 Drug An Analysis of Deficiencies Observed During On-Site Good Manufacturing Practice (GMP) Inspections of Local and Foreign Manufacturing Premise of Medicinal Registered Products in the Year 2022 Regulatory Visit Page
Europe European Medicines Agency 3-4-23 Drug Clinical Trial Highlights Clinical Visit Page
Malaysia National Pharmaceutical Regulatory Agency 3-4-23 Drug Guideline on electronic labelling (E-LABELLING) for pharmaceutical products in malaysia Regulatory Visit Page
International International Medical Device Regulators Forum 3-4-23 Medical Device Personalized Medical Devices – Production Verification and Validation Regulatory Visit Page
International International Medical Device Regulators Forum 3-4-23 Medical Device Principles and Practices for the Cybersecurity of Legacy Medical Devices Regulatory Visit Page
International International Medical Device Regulators Forum 3-4-23 Medical Device Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity Regulatory Visit Page
International International Council for Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use 3-4-23 Drug Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk M7(R2) Clinical Visit Page
International International Council for Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use 3-4-23 Drug Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Addendum to M7(R2) Clinical Visit Page
Australia Therapeutic Goods Administration 3-4-23 Drug Health Technology Assessment Policy and Methods Review Consultation 1 Survey Questions Regulatory Visit Page
USA Food and Drug Administration 3-4-23 Medical Device Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 3-4-23 Medical Device Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (draft guidance Regulatory Visit Page
USA Food and Drug Administration 3-4-23 Drug Mpox: Development of Drugs and Biological Products (draft guidance) Clinical Visit Page
The Philippines Philippines FDA 1-4-23 Medical Device Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices Regulatory Visit Page
USA Food and Drug Administration 1-4-23 Drug Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-4-23 Drug Over-the-Counter Monograph Order Requests (OMORs): Format and Content (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-4-23 Drug Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-4-23 Drug Assessing Adhesion with Transdermal and Topical Delivery (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-4-23 Drug A Risk-Based Approach to Monitoring of Clinical Investigations Clinical Visit Page
USA Food and Drug Administration 1-4-23 Drug Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-4-23 Drug Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making (draft guidance) Regulatory Visit Page
Europe European Medicines Agency 31-3-23 Drug Regulatory information – adjusted fees for applications to EMA from 1 April 2023 Regulatory Visit Page
Europe European Medicines Agency 30-3-23 Drug Guideline on influenza vaccines – submission and procedural requirements Regulatory Visit Page
Europe European Medicines Agency 30-3-23 Drug EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters, or other major disruptions Clinical Visit Page
Europe European Union 30-3-23 Medical Device Questions and answers on data requirements when replacing hydrofluorocarbons as propellants in oral pressurized metered dose inhalers Regulatory Visit Page
USA Food and Drug Administration 30-3-23 Medical Device Medical Device Development Tools (MDDT) Regulatory Visit Page
USA Food and Drug Administration 30-3-23 Medical Device Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act Regulatory Visit Page
India Indian Pharmacopoeia Commission 29-3-23 Vaccine Substitution of in-vivo Method(s) by in-vitro Method(s) for the Quality Control of Vaccines Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 29-3-23 Medical Device MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured Regulatory Visit Page
USA Food and Drug Administration 29-3-23 Medical Device Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions (draft guidance) Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 28-3-23 Medical Device Extension of CE certificates Regulatory Visit Page
USA Food and Drug Administration 28-3-23 Medical Device General Considerations for Animal Studies Intended to Evaluate Medical Devices Safety Visit Page
Switzerland The Swiss Agency for Therapeutic Products 27-3-23 Medical Device Findings on manufacturers failing to meet post market surveillance requirements Regulatory Visit Page
USA Food and Drug Administration 27-3-23 Drug Update on In-Person Face-to-Face ANDA Meetings Regulatory Visit Page
USA Food and Drug Administration 27-3-23 Medical Device Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Regulatory Visit Page
USA Food and Drug Administration 27-3-23 Medical Device Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) Regulatory Visit Page
Australia Therapeutic Goods Administration 24-3-23 Drug TGA’s new powers will help reduce the impact of medicine shortages on patients Regulatory Visit Page
Malaysia Medical Device Authority 23-3-23 Medical Device Withdrawal of medical device registration (new and re-register) and change of notification application Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 21-3-23 Drug Consultation outcome - Government response to consultation on legislative proposals for clinical trials Clinical Visit Page
UK Medicines and Healthcare products Regulatory Agency 21-3-23 Drug MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years Clinical Visit Page
Australia Therapeutic Goods Administration 20-3-23 Drug GMP Clearance: Additional countries added to MRA pathway Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 20-3-23 Medical Device Request for an update of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties Safety Visit Page
Malaysia National Pharmaceutical Regulatory Agency 17-3-23 Drug Topiramate: Neurodevelopmental disorders in children exposed to topiramate during pregnancy Regulatory Visit Page
Argentina ANMAT 16-3-23 Drug ANMAT signed a Memorandum of Understanding with the United States Pharmacopoeia Regulatory Visit Page
USA Food and Drug Administration 16-3-23 Drug Pharmacogenomic Data Submissions (draft guidance) Regulatory Visit Page
Malaysia National Pharmaceutical Regulatory Agency 13-3-23 Drug Declaration of Worldwide Registration Status for Generic Medicines in QUEST System Regulatory Visit Page
USA Food and Drug Administration 10-3-23 Drug Evaluation of Gastric pH Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications Clinical Visit Page
Europe European Medicines Agency 9-3-23 Drug Guideline on computerized systems and electronic data in clinical trials Regulatory Visit Page
Malaysia Medical Device Authority 8-3-23 Medical Device Classification of rehabilitation, physiotherapy, and speech therapy device Regulatory Visit Page
Europe European Medicines Agency 8-3-23 Medical Device Amendment of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (MDR) Regulatory Visit Page
Europe European Medicines Agency 8-3-23 Medical Device Amendment of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (IVDR) Regulatory Visit Page
Europe European Medicines Agency 7-3-23 Medical Device Council takes action to mitigate risk of medical devices shortage y extending the MDR deadlines Regulatory Visit Page
Europe European Medicines Agency 7-3-23 Drug Questions and Answers about the raw data proof-of-concept pilot for industry Clinical Visit Page
UK Medicines and Healthcare products Regulatory Agency 7-3-23 Medical Device Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform Regulatory Visit Page
USA Food and Drug Administration 7-3-23 Drug Nitrosamine Impurities: Latest USP Tool Further Aids Understanding and Control Regulatory Visit Page
USA Food and Drug Administration 6-3-23 Food & Food Supplement FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements Safety Visit Page
The Philippines Philippines FDA 6-3-23 Drug Guidelines on Regulatory Reliance on the Conduct of Clinical Trials Clinical Visit Page
USA Food and Drug Administration 4-3-23 Medical Device Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway Regulatory Visit Page
Europe European Medicines Agency 3-3-23 Drug European Pharmacopoeia Commission creates new Excipients Strategy Working Party Regulatory Visit Page
USA Food and Drug Administration 2-3-23 Drug Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for Industry Regulatory Visit Page
International World Health Organization 1-3-23 Drug WHO Good Manufacturing Practices for excipients used in pharmaceutical products Regulatory Visit Page
USA Food and Drug Administration 1-3-23 Drug Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP (draft guidance) Clinical Visit Page
USA Food and Drug Administration 1-3-23 Medical Device Identification of Medicinal Products — Implementation and Use Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 1-3-23 Drug New Mobile technologies guidance document for human and veterinary medicinal products Packaging Visit Page
Europe European Medicines Agency 1-3-23 Medical Device Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP) Clinical Visit Page
USA Food and Drug Administration 1-3-23 Drug Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (draft guidance) Clinical Visit Page
USA Food and Drug Administration 1-3-23 Drug Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act Regulatory Visit Page
USA Food and Drug Administration 1-3-23 Drug Development of Local Anesthetic Drug Products with Prolonged Duration of Effect Clinical Visit Page
USA Food and Drug Administration 1-3-23 Medical Device Total Product Life Cycle Advisory Program (TAP) Regulatory Visit Page
USA Food and Drug Administration 1-3-23 Drug Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments Pharmacovigilance Visit Page
Malaysia Medical Device Authority 28-2-23 Medical Device Notification of custom-made medical device Regulatory Visit Page
USA Food and Drug Administration 28-2-23 Drug CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Program Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 27-2-23 Drug Windsor Framework unveiled to fix problems of the Northern Ireland Protocol Regulatory Visit Page
Europe European Medicines Agency 22-2-23 Drug Question and Answer on the submission of applications for the expert panels’ advice to manufacturers Regulatory Visit Page
Europe European Medicines Agency 9-2-23 Drug Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR) Clinical Visit Page
International International Medical Device Regulators Forum 7-2-23 Medical Device IMDRF Terms of Reference Regulatory Visit Page
Australia Therapeutic Goods Administration 1-2-23 Medical Device Changes to medical device essential principles for nanomaterials Regulatory Visit Page
USA Food and Drug Administration 31-1-23 Medical Device Surveying, Leveling, and Alignment Laser Products Regulatory Visit Page
Mexico COFEPRIS 25-1-23 Drug Mexico proposes a Latin American Medicines Agency for health self-sufficiency Regulatory Visit Page
USA Food and Drug Administration 20-1-23 Medical Device Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions Regulatory Visit Page
USA Food and Drug Administration 20-1-23 Medical Device Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye Regulatory Visit Page
USA Food and Drug Administration 20-1-23 Medical Device Radiological Health Regulations: Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products Regulatory Visit Page
Malaysia Medical Device Authority 13-1-23 Medical Device Requirements for application of Certificate Of Free Sale (CFS), Manufacturing Certificate (MC) and Certificate Of Free Sale For Export only (CFS EO) medical devices (draft guidance) Regulatory Visit Page
Europe European Union 6-1-23 Medical Device More time to certify medical devices under MDR to mitigate risks of shortages Regulatory Visit Page
Europe European Medicines Agency 3-1-23 Drug Coordination of pharmacovigilance inspections Pharmacovigilance Visit Page
Europe European Union 3-1-23 Medical Device List of standard fees Regulatory Visit Page
Europe European Medicines Agency 3-1-23 Drug Pharmeuropa 35.1 just released Regulatory Visit Page
USA Food and Drug Administration 1-1-23 Drug Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (draft guidance) Clinical Visit Page
Malaysia Medical Device Authority 1-1-23 Medical Device Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation Regulatory Visit Page
The Netherlands Medicines Evaluation Board 1-1-23 Drug Changes to fees for human medicinal products and devices as of 1 January 2023 Regulatory Visit Page
USA Food and Drug Administration 23-12-22 Drug FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs Regulatory Visit Page
USA Food and Drug Administration 22-12-22 Drug Controlled Correspondence Related to Generic Drug Development (draft guidance) Regulatory Visit Page
Ireland The International Council for Harmonisation 20-12-22 Drug Bioequivalence for immediate release solid oral dosage forms M13A Regulatory Visit Page
USA Food and Drug Administration 20-12-22 Medical Device Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices Safety Visit Page
International International Medical Device Regulators Forum 19-12-22 Medical Device IMDRF Standard Operating Procedures - Edition 8 Regulatory Visit Page
Europe European Medicines Agency 16-12-22 Drug EMA Management Board: highlights of December 2022 meeting Regulatory Visit Page
Europe European Union 16-12-22 Medical Device Guidance on Periodic Safety Update Report (PSUR) according to regulation (EU) 2017/745 (MDR) Safety Visit Page
USA Food and Drug Administration 15-12-22 Drug Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 15-12-22 Drug Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (draft guidance) Regulatory Visit Page
Singapore Health Sciences Authority 14-12-22 Drug Mean applicant screening response time Regulatory Visit Page
USA Food and Drug Administration 14-12-22 Drug FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal Labeling Visit Page
USA Food and Drug Administration 14-12-22 Drug Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe Regulatory Visit Page
Europe European Union 14-12-22 Medical Device Substantial modification of performance study under Regulation (EU) 2017/746 Regulatory Visit Page
India Central Drugs Standard Control Organisation 13-12-22 Drug Inspections/Audits of Pharmacovigilance (PV) system of importers and manufacturers of human vaccine Pharmacovigilance Visit Page
Europe European Union 13-12-22 Drug Commission proposes updated EMA fees Regulatory Visit Page
USA Food and Drug Administration 9-12-22 Drug Pulmonary Tuberculosis: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
Australia Therapeutic Goods Administration 9-12-22 Drug Safety advisory - Low levels of contamination with N-nitroso-quinapril Safety Visit Page
USA Food and Drug Administration 9-12-22 Medical Device Content of Human Factors Information in Medical Device Marketing Submissions (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 9-12-22 Drug CMC Reviews of Type III DMFs for Packaging Materials Packaging Visit Page
USA Food and Drug Administration 9-12-22 Drug Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria Regulatory Visit Page
USA Food and Drug Administration 9-12-22 Medical Device Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 8-12-22 Drug Acceptability of Standards from Alternative Compendia (BP/EP/JP) Regulatory Visit Page
Europe European Union 8-12-22 Medical Device MDCG position paper on ‘hybrid audits’ Regulatory Visit Page
India Central Drugs Standard Control Organisation 7-12-22 Drug Changes to pharmaceutical database based on feedback received Regulatory Visit Page
USA Food and Drug Administration 7-12-22 Medical Device Augmented Reality and Virtual Reality in Medical Devices Regulatory Visit Page
USA Food and Drug Administration 7-12-22 Drug Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q) Regulatory Visit Page
Europe European Union 6-12-22 Medical Device Proposal to delay the implementation of the Medical Device Regulation Regulatory Visit Page
USA Food and Drug Administration 6-12-22 Drug Homeopathic Drug Products Regulatory Visit Page
USA Food and Drug Administration 5-12-22 Drug E19 A selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials Clinical Visit Page
USA Food and Drug Administration 5-12-22 Drug Statistical Approaches to Establishing Bioequivalence (draft guidance) Regulatory Visit Page
Europe European Union 2-12-22 Medical Device Regulations to lay down common specifications and rules for reclassification of products without an intended medical purpose under the Medical Devices Regulation (MDR) Regulatory Visit Page
Europe European Medicines Agency 2-12-22 Drug EMA recommends withdrawal of pholcodine medicines from EU market Regulatory Visit Page
USA Food and Drug Administration 2-12-22 Drug ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (draft guidance) Regulatory Visit Page
Australia Therapeutic Goods Administration 30-11-22 Drug A warning that advertising Ozempic (semaglutide) is prohibited Labeling Visit Page
Ireland Health Products Regulatory Authority 28-11-22 Drug Update on review of over-the-counter medicines containing codeine. Regulatory Visit Page
Malaysia Medical Device Authority 21-11-22 Medical Device Change notification for registered medical device Regulatory Visit Page
Malaysia Medical Device Authority 21-11-22 Drug NMPA Announcement on putting into use the electronic certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product Regulatory Visit Page
USA Food and Drug Administration 17-11-22 Drug Upcoming Product-Specific Guidances for Generic Drug Product Development Regulatory Visit Page
International International Council for Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use 16-11-22 Drug Continuous manufacturing of drug substances and drug products Q13 Regulatory Visit Page
USA Food and Drug Administration 14-11-22 Medical Device Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents Regulatory Visit Page
Indonesia BADAN POM 9-11-22 Drug Explanation of BPOM RI number HM.01.1.2.11.22.178 dated 9 November 2022 regarding development of results of supervision of drug syrup and procedure of propylene glycol raw materials containing contaminants EG and DEG exceed the limits Regulatory Visit Page
Malaysia Medical Device Authority 9-11-22 Medical Device Notification of custom-made medical device - Guidance document Regulatory Visit Page
India Medicines and Healthcare products Regulatory Agency 8-11-22 Drug Submission of Suspected Unexpected Serious Adverse Reactions reports using ICSR submissions or MHRA gateway Safety Visit Page
Australia Therapeutic Goods Administration 7-11-22 Drug International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names Labeling Visit Page
UK Medicines and Healthcare products Regulatory Agency 7-11-22 Biologics Guidance on the licensing of biosimilar products Regulatory Visit Page
Australia Therapeutic Goods Administration 7-11-22 Drug International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names Labeling Visit Page
UK Medicines and Healthcare products Regulatory Agency 7-11-22 Biologics Guidance on the licensing of biosimilar products Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 4-11-22 Drug Changes to the Guidance document Variations TAM HMV4 Regulatory Visit Page
USA The Swiss Agency for Therapeutic Products 4-11-22 Drug Changes to the Guidance document Variations TAM HMV4 Regulatory Visit Page
Europe European Medicines Agency 3-11-22 Drug Regulatory update - EMA encourages companies to submit type I variations for 2022 by end of November Regulatory Visit Page
Australia Therapeutic Goods Administration 3-11-22 Medical Device Post-market review of spinal cord stimulation (SCS) devices Pharmacovigilance Visit Page
Europe European Medicines Agency 3-11-22 Drug Regulatory update - EMA encourages companies to submit type I variations for 2022 by end of November Regulatory Visit Page
Australia Therapeutic Goods Administration 3-11-22 Medical Device Post-market review of spinal cord stimulation (SCS) devices Pharmacovigilance Visit Page
The Philippines Philippines FDA 1-11-22 Drug Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration Regulatory Visit Page
The Philippines Philippines FDA 1-11-22 Drug Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National Public Health Emergencies Regulatory Visit Page
USA Food and Drug Administration 1-11-22 Drug Sameness Evaluations in an ANDA — Active Ingredients (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-11-22 Biologics Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulatory Visit Page
USA Food and Drug Administration 1-11-22 Drug M10 Bioanalytical method validation and study sample analysis Regulatory Visit Page
USA Food and Drug Administration 1-11-22 Drug Sameness Evaluations in an ANDA — Active Ingredients (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-11-22 Biologics Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulatory Visit Page
USA Food and Drug Administration 1-11-22 Drug M10 Bioanalytical method validation and study sample analysis Regulatory Visit Page
USA Food and Drug Administration 1-11-22 Drug Cross Labeling Oncology Drugs in Combination Regimens Labeling Visit Page
USA Food and Drug Administration 1-11-22 Drug S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals Non-Clinical Visit Page
USA Food and Drug Administration 1-11-22 Biologics Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial Clinical Visit Page
USA Food and Drug Administration 1-11-22 Drug Expanded Access to Investigational Drugs for Treatment Use Questions and Answers (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 31-10-22 Drug Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement - updated on 10/31/2022 Regulatory Visit Page
Europe European Union 28-10-22 Drug The Council of Europe/EDQM and the European Union conclude an agreement expanding the scope of their co-operation in the field of substances of human origin Regulatory Visit Page
India Central Drugs Standard Control Organisation 27-10-22 Drug IPC's Notice Regarding General Chapters of IP 2022 Regulatory Visit Page
India Central Drugs Standard Control Organisation 27-10-22 Drug IPC's Notice Regarding General Chapters of IP 2022 Regulatory Visit Page
USA Food and Drug Administration 27-10-22 Drug Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials (draft guidance) Clinical Visit Page
USA Food and Drug Administration 26-10-22 Drug Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 25-10-22 Medical Device Implementation of the Future Regulations Regulatory Visit Page
USA Food and Drug Administration 25-10-22 Drug In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 25-10-22 Drug Human Gene Therapy for Neurodegenerative Diseases Clinical Visit Page
Europe European Medicines Agency 24-10-22 Drug Information about the raw data proof-of-concept pilot for industry Clinical Visit Page
USA Food and Drug Administration 21-10-22 Drug In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 21-10-22 Drug Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 21-10-22 Drug Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (draft guidance) Regulatory Visit Page
Australia Therapeutic Goods Administration 21-10-22 Drug GMP Clearance: Temporary changes to target processing times Regulatory Visit Page
USA Food and Drug Administration 21-10-22 Medical Device Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 20-10-22 Drug Multiple Endpoints in Clinical Trials Clinical Visit Page
USA Food and Drug Administration 19-10-22 Drug Advancing Real-World Evidence Program Regulatory Visit Page
Europe European Medicines Agency 18-10-22 Drug Anonymization of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6) Pharmacovigilance Visit Page
Europe European Medicines Agency 18-10-22 Drug Anonymization of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6) Pharmacovigilance Visit Page
UK Medicines and Healthcare products Regulatory Agency 17-10-22 Medical Device Software and AI as a Medical Device Change Programme - Roadmap Regulatory Visit Page
USA Food and Drug Administration 17-10-22 Drug Complex Generics News Regulatory Visit Page
Europe European Medicines Agency 14-10-22 Drug European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance Clinical Visit Page
India Central Drugs Standard Control Organisation 11-10-22 Medical Device EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products Regulatory Visit Page
USA Food and Drug Administration 5-10-22 Drug Prioritization of the Review of Original ANDAs, Amendments, and Supplements Regulatory Visit Page
USA Food and Drug Administration 5-10-22 Drug Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA Regulatory Visit Page
USA Food and Drug Administration 5-10-22 Drug Information Requests and Discipline Review Letters Under GDUFA Regulatory Visit Page
USA Food and Drug Administration 5-10-22 Drug Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA Regulatory Visit Page
USA Food and Drug Administration 5-10-22 Drug Competitive Generic Therapies Regulatory Visit Page
USA Food and Drug Administration 3-10-22 Drug Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 3-10-22 Drug Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (draft guidance) Regulatory Visit Page
Europe European Union 3-10-22 Medical Device Guidance on Authorized Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) Regulatory Visit Page
USA Food and Drug Administration 3-10-22 Drug Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA (Draft guidance) Regulatory Visit Page
USA Food and Drug Administration 3-10-22 Medical Device FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals Regulatory Visit Page
USA Food and Drug Administration 3-10-22 Medical Device FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals Regulatory Visit Page
USA Food and Drug Administration 3-10-22 Medical Device FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals Regulatory Visit Page
USA Food and Drug Administration 3-10-22 Drug Facility Readiness: Goal Date Decisions Under GDUFA (Draft guidance) Regulatory Visit Page
USA Food and Drug Administration 3-10-22 Drug Split Real Time Application Review (STAR) Regulatory Visit Page
International International Council for Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use 27-9-22 Drug Clinical electronic structured harmonized protocol (CESHARP) M11 Clinical Visit Page
The Philippines Philippines FDA 27-9-22 Medical Device Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country Regulatory Visit Page
Europe European Commission 10-8-22 Medical Device MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies Regulatory Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 4-8-22 Drug itrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023) Regulatory Visit Page
India Central Drugs Standard Control Organisation 4-8-22 Medical Device Classification of medical devices pertaining to rehabilitation under the provisions of Medical Devices rule Regulatory Visit Page
India Central Drugs Standard Control Organisation 4-8-22 Medical Device Classification of medical devices pertaining to rehabilitation under the provisions of Medical Devices rule Regulatory Visit Page
India Central Drugs Standard Control Organisation 29-7-22 Medical Device MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies Regulatory Visit Page
India Central Drugs Standard Control Organisation 29-7-22 Medical Device Price control on medical devices Regulatory Visit Page

Country/Region

USA

Date of Publishing

8-5-24

Product Type

Drug

Topic

CDER Center for Clinical Trial Innovation (C3TI)

Domain

Clinical

URL

Country/Region

Malaysia

Date of Publishing

30-4-24

Product Type

Drug

Topic

Guideline for application of clinical trial import licence and clinical trial exemption

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

25-4-24

Product Type

Medical Device

Topic

Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

24-4-24

Product Type

Drug

Topic

Nitrosamine impurities acceptable intakes update

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-4-24

Product Type

Medical Device

Topic

Charting the path forward: Joint stakeholder statement on the implementation of the EHDS

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

16-4-24

Product Type

Drug

Topic

Prescribing the Guidelines on Good Manufacturing Practice (GMP) for Drug Manufacturers Repealing AO No. 2013-0022 (draft for comments)

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

15-4-24

Product Type

Drug

Topic

Clarification on the requirements for change of Qualified Person initially registered in a licensed drug establishment

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

12-4-24

Product Type

Drug

Topic

Updates in uniform Rules for conducting bioequivalence studies of medicinal products

Domain

Clinical

URL

Country/Region

International

Date of Publishing

12-4-24

Product Type

Drug

Topic

Updates in the unified Rules for conducting pharmaceutical inspections of pharmacovigilance systems of drug manufacturers

Domain

Pharmacovigilance

URL

Country/Region

New Zealand

Date of Publishing

11-4-24

Product Type

Medical Device

Topic

Outcome of the consultation on standards for contraceptive devices in New Zealand

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

10-4-24

Product Type

Drug

Topic

CBER Rare Disease Program

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

9-4-24

Product Type

Drug

Topic

JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs

Domain

Regulatory

URL

Country/Region

Japan

Date of Publishing

8-4-24

Product Type

Drug

Topic

New drug review with electronic data

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

8-4-24

Product Type

Drug

Topic

Malaysian guideline for Bioequivalence inspection 2nd edition (draft for comments)

Domain

Clinical

URL

Country/Region

Brazil

Date of Publishing

8-4-24

Product Type

Medical Device

Topic

ANVSIA will use assessment from foreign authorities to register medical devices

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

5-4-24

Product Type

Drug

Topic

Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

5-4-24

Product Type

Drug

Topic

UK Parallel Import Licences Following Agreement of the Windsor Framework

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

4-4-24

Product Type

Drug

Topic

As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

3-4-24

Product Type

Medical Device

Topic

Strengthening of private medical devices testing laboratory in India

Domain

Regulatory

URL

Country/Region

Ireland

Date of Publishing

3-4-24

Product Type

Drug

Topic

Submitting a Request for a New National Application Procedure for a Human Medicinal Product

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

2-4-24

Product Type

Drug

Topic

Updated guidelines for Assessed listed medicines

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

1-4-24

Product Type

Drug

Topic

WHO Good Manufacturing Practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products (draft for comments)

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

1-4-24

Product Type

Drug

Topic

Guidelines on the Classification of Deficiencies Observed During Inspection of Drug Distributors, Drugstores, Hospital Pharmacies and Retail Outlet for Non-Prescription Drugs (RONPD) (draft for comments)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-4-24

Product Type

Medical Device

Topic

Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

1-4-24

Product Type

Medical Device

Topic

Guidance on content of the Investigator’s Brochure for clinical investigations of medical devices

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

1-4-24

Product Type

Medical Device

Topic

Consultation: Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods (draft for comments)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-4-24

Product Type

Medical Device

Topic

Instructions for Use for Medical Devices Consultation on availability of instructions for use in more flexible formats (draft for comments)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-4-24

Product Type

Topic

Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products Questions and Answers (draft for comments)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-4-24

Product Type

Drug

Topic

Data Integrity for In Vivo Bioavailability and Bioequivalence Studies (draft for comments)

Domain

Quality

URL

Country/Region

USA

Date of Publishing

1-4-24

Product Type

Drug

Topic

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies

Domain

Safety

URL

Country/Region

USA

Date of Publishing

1-4-24

Product Type

Drug

Topic

Providing Regulatory Submissions in Electronic Format: IND Safety Reports

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

29-3-24

Product Type

Medical Device

Topic

Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions

Domain

Non-Clinical

URL

Country/Region

Europe

Date of Publishing

28-3-24

Product Type

Drug

Topic

How CEP holders can avoid the rejection of notifications

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

28-3-24

Product Type

Medical Device

Topic

First OMCL analytical procedures for determination of nitrosamine drug substance-related impurities (NDSRIs) and intermediate-related contaminants published

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

27-3-24

Product Type

Drug

Topic

European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

25-3-24

Product Type

Drug

Topic

HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorization application (MAA) dossier (draft for comments)

Domain

Quality

URL

Country/Region

Europe

Date of Publishing

25-3-24

Product Type

Drug

Topic

Guideline on quality, non-clinical and clinical requirements for investigational advanced

Domain

Clinical

URL

Country/Region

Brazil

Date of Publishing

22-3-24

Product Type

Drug

Topic

Anvisa extends the validity period of the Good Manufacturing Practices Certificate to four years

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

20-3-24

Product Type

Drug

Topic

Outcome of the consultation on the proposed updates to the Guideline on the Regulation of Therapeutic Products in New Zealand: Pharmacovigilance

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

20-3-24

Product Type

Drug

Topic

Commission takes action to boost biotechnology and biomanufacturing in the EU

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

18-3-24

Product Type

Drug

Topic

IPC signs Memorandum of Understanding with USP

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

16-3-24

Product Type

Drug

Topic

Guideline on the requirements for demonstrating therapeutic equivalence between orally inhaled products (OIP) for asthma and chronic obstructive pulmonary disease (COPD)

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

15-3-24

Product Type

Medical Device

Topic

Draft guidance: Review of first-in-human high-risk implantable or cardiac invasive medical device clinical trials and Investigator’s brochures for medical device clinical trials

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

15-3-24

Product Type

Medical Device

Topic

Companion diagnostics guidance update- public consultation (draft for comments)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

15-3-24

Product Type

Drug

Topic

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

15-3-24

Product Type

Medical Device

Topic

Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

14-3-24

Product Type

Cosmetic

Topic

MedTech Europe views on the ‘One Substance, One Assessment’ European Commission package of legislative proposals

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

13-3-24

Product Type

Drug

Topic

New Organization First User EU QPPV/RP or Change of EU QPPV/RP

Domain

Pharmacovigilance

URL

Country/Region

USA

Date of Publishing

13-3-24

Product Type

Medical Device

Topic

Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act (draft guidance)

Domain

Quality

URL

Country/Region

USA

Date of Publishing

12-3-24

Product Type

Medical Device

Topic

Banned Devices; Proposal to Ban Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

12-3-24

Product Type

Drug

Topic

Drug Products or Categories of Drug Products That Present Demonstrable Difficulties for Compounding Under Sections 503A or 503B of the Federal Food, Drug, and Cosmetic Act

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

12-3-24

Product Type

Drug

Topic

Pharmacokinetics in Patients with Impaired Renal Function – Study Design, Data Analysis, and Impact on Dosing; Guidance for Industry;

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

11-3-24

Product Type

Drug

Topic

Commission proposes new measures for the better lifecycle management of medicine authorisations

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

11-3-24

Product Type

Medical Device

Topic

MHRA response to Equity in Medical Devices: Independent Review

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

7-3-24

Product Type

Cosmetic

Topic

Advertising health services

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

4-3-24

Product Type

Drug

Topic

Public consultation on ICH Guideline E2D(R1) launched in Switzerland

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

1-3-24

Product Type

Medical Device

Topic

Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices

Domain

Clinical

URL

Country/Region

UK

Date of Publishing

1-3-24

Product Type

Drug

Topic

Established medicines: marketing authorisation application changes

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Handling and Retention of BA and BE Testing Samples (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Real-World Evidence: Considerations Regarding Non-Interventional Studies for Drug and Biological Products (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Controlled Correspondence Related to Generic Drug Development

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Controlled Correspondence Related to Generic Drug Development

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Annual Reportable Labeling Changes for NDAs and ANDAs for Nonprescription Drug Products (draft guidance)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Q14 Analytical Procedure Development

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Q2(R2) Validation of Analytical Procedures

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Drug

Topic

Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards (draft for guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-3-24

Product Type

Medical Device

Topic

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number: 061

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-2-24

Product Type

Biologics

Topic

Good Review Practice: Management of Breakthrough Therapy-Designated Drugs and Biologics

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

12-2-24

Product Type

Drug

Topic

Guideline on the pharmaceutical quality of inhalation and nasal medicinal products

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

2-2-24

Product Type

Drug

Topic

Post approval changes in biologics – Quality, safety and efficacy documents

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-2-24

Product Type

Drug

Topic

Reporting Amount of Listed Drugs and Biological Products Technical Conformance Guide

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

23-1-24

Product Type

Medical Device

Topic

Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices; Draft Guidance for Industry and Food and Drug Administration Staff

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

23-1-24

Product Type

Drug

Topic

Innovation in medicines

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

15-1-24

Product Type

Drug

Topic

Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products

Domain

Safety

URL

Country/Region

USA

Date of Publishing

8-1-24

Product Type

Drug

Topic

SOPP 8401: Administrative Processing of Original Biologics License Applications (BLA) and New Drug Applications (NDA)

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

31-12-23

Product Type

Drug

Topic

Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

15-12-23

Product Type

Drug

Topic

SOPP 8201: Administrative Processing of Clinical Holds for Investigational New Drug Applications

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-12-23

Product Type

Drug

Topic

Quality Considerations for Topical Ophthalmic Drug Products (draft guidance)

Domain

Quality

URL

Country/Region

Europe

Date of Publishing

28-11-23

Product Type

Medical Device

Topic

COFEPRIS accepts GMP certificates issued by WHO accredited Health Authorities/PIC/S

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

20-11-23

Product Type

Drug

Topic

Interleukin inhibitors and the possible risk of pancreatitis

Domain

Safety

URL

Country/Region

Australia

Date of Publishing

20-11-23

Product Type

Drug

Topic

New medicine adverse event search for sponsors

Domain

Safety

URL

Country/Region

Mexico

Date of Publishing

13-11-23

Product Type

Drug

Topic

Modifications to health registration conditions, regulatory simplification strategy

Domain

Regulatory

URL

Country/Region

China

Date of Publishing

9-11-23

Product Type

Drug

Topic

NMPA becomes the applicant for PIC/S

Domain

Regulatory

URL

Country/Region

Ireland

Date of Publishing

9-11-23

Product Type

Drug

Topic

Outcome of the Process - Public Consultation on proposed fees for Human Medicines, Compliance, Medical Devices and Veterinary Medicines for 2024

Domain

Regulatory

URL

Country/Region

Brazil

Date of Publishing

8-11-23

Product Type

Drug

Topic

ANMAT and ANVISA signed the first Mutual Recognition agreement on certificates for Medical Products

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

8-11-23

Product Type

Drug

Topic

ICH adopts Q5A(R2) guideline on viral safety evaluation of biotechnology products and validation of analytical procedures Q2(R2)

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

6-11-23

Product Type

Drug

Topic

International Recognition Procedure

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-11-23

Product Type

Medical Device

Topic

Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-11-23

Product Type

Drug

Topic

Guideline for facilitated registration pathway

Domain

Regulatory

URL

Country/Region

Japan

Date of Publishing

1-11-23

Product Type

Drug

Topic

Pharmaceuticals and Medical Devices Safety Information No. 405 November 2023

Domain

Safety

URL

Country/Region

International

Date of Publishing

31-10-23

Product Type

Drug

Topic

Landmark listing of first three countries as WHO-Listed regulatory Authorities

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-10-23

Product Type

Medical Device

Topic

Good Machine Learning Practice for Medical Device Development: Guiding Principles

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

24-10-23

Product Type

Drug

Topic

EMA takes further steps to address critical shortages of medicines in the EU

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

24-10-23

Product Type

Medical Device

Topic

Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

20-10-23

Product Type

Medical Device

Topic

Amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

19-10-23

Product Type

Drug

Topic

Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products Questions and Answers (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

19-10-23

Product Type

Medical Device

Topic

Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

18-10-23

Product Type

Medical Device

Topic

Team-NB asks manufacturers of class D devices to submit IVDR filings

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

12-10-23

Product Type

Drug

Topic

Guideline on the Development and Manufacture of Synthetic Peptides

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

10-10-23

Product Type

Medical Device

Topic

Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

10-10-23

Product Type

Medical Device

Topic

Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

5-10-23

Product Type

Drug

Topic

Pharmacopoeial Discussion Group welcomes Indian Pharmacopoeia Commission as a member, facilitating reach and enhancing impact of pharmacopoeial standards harmonisation

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-23

Product Type

Drug

Topic

Filing Review of Abbreviated New Drug Applications

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-10-23

Product Type

Drug

Topic

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence Guidance for Industry (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

2-10-23

Product Type

Drug

Topic

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-10-23

Product Type

Drug

Topic

Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-10-23

Product Type

Drug

Topic

Diabetic Foot Infections: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

2-10-23

Product Type

Drug

Topic

Guidelines for the Use of Doxycycline Post-Exposure Prophylaxis for Bacterial Sexually Transmitted Infection (STI) Prevention; Request for Comment and Informational Presentation

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

2-10-23

Product Type

Drug

Topic

Stimulant Use Disorders: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

2-10-23

Product Type

Drug

Topic

Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Readyto-Use Containers — “Dose Banding”

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

1-10-23

Product Type

Drug

Topic

Nitrosamine impurities

Domain

Safety

URL

Country/Region

USA

Date of Publishing

29-9-23

Product Type

Medical Device

Topic

Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

29-9-23

Product Type

Medical Device

Topic

Electronic Submission Template for Medical Device De Novo Requests

Domain

Publishing

URL

Country/Region

USA

Date of Publishing

29-9-23

Product Type

Medical Device

Topic

Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling

Domain

Labeling

URL

Country/Region

UK

Date of Publishing

29-9-23

Product Type

Drug

Topic

Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

27-9-23

Product Type

Medical Device

Topic

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

22-9-23

Product Type

Medical Device

Topic

Electronic Submission Template for Medical Device 510(k) Submissions

Domain

Publishing

URL

Country/Region

Singapore

Date of Publishing

21-9-23

Product Type

Drug

Topic

HSA is assessing the potential risk of suicidal thoughts and self-harm with glucagon-like peptide-1 receptor agonists (GLP-1 RA)

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

21-9-23

Product Type

Medical Device

Topic

Changes to the acceptability of CEP applications for sterile grade materials

Domain

Regulatory

URL

Country/Region

Ireland

Date of Publishing

20-9-23

Product Type

Drug

Topic

Guide for National Scientific and Regulatory Advice

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

19-9-23

Product Type

Medical Device

Topic

The Innovative Devices Access Pathway (IDAP)

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

15-9-23

Product Type

Drug

Topic

Changes to the guidance document Temporary authorisation of human medicinal products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

15-9-23

Product Type

Medical Device

Topic

Medical Devices with Indications Associated with Weight Loss - Non-Clinical Recommendations (draft guidance)

Domain

Non-Clinical

URL

Country/Region

USA

Date of Publishing

15-9-23

Product Type

Medical Device

Topic

Medical Devices with Indications 2 Associated with Weight Loss - Clinical 3 Study and Benefit-Risk Considerations (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

15-9-23

Product Type

Drug

Topic

Quality Management Maturity Program for Drug Manufacturing Establishments; Establishment of a Public Docket; Request for Comments

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

11-9-23

Product Type

Drug

Topic

Post market responsibilities for manufacturers and sponsors of medical devices

Domain

Pharmacovigilance

URL

Country/Region

USA

Date of Publishing

11-9-23

Product Type

Drug

Topic

Demonstrating Substantial Evidence of Effectiveness with One Adequate and Well-Controlled Clinical Investigation and Confirmatory Evidence (draft guidance)

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

10-9-23

Product Type

Drug

Topic

Swiss GMDP database

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

4-9-23

Product Type

Drug

Topic

Processing of adverse reaction reports received in New Zealand

Domain

Safety

URL

Country/Region

Colombia

Date of Publishing

1-9-23

Product Type

Drug

Topic

Renewal of medicinal product approvals – No longer required

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

1-9-23

Product Type

Medical Device

Topic

Personalized Medical Devices – Regulatory Pathways

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

1-9-23

Product Type

Drug

Topic

FAQs: General Pharmacovigilance

Domain

Pharmacovigilance

URL

Country/Region

Australia

Date of Publishing

1-9-23

Product Type

Drug

Topic

Changes to the regulation of sports supplements in medicinal dosage forms

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

1-9-23

Product Type

Medical Device

Topic

Q&A on transitional provisions for products without an intended medical purpose covered by Annex XVI of the MDR

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-9-23

Product Type

Biologics

Topic

Questions and answers for biological medicinal products

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-9-23

Product Type

Drug

Topic

Guideline on clinical investigation of medicinal products in the treatment of depression

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

1-9-23

Product Type

Drug

Topic

PRAC recommends new measures to avoid topiramate exposure in pregnancy

Domain

Pharmacovigilance

URL

Country/Region

USA

Date of Publishing

1-9-23

Product Type

Medical Device

Topic

Regulatory Considerations for Prescription Drug Use Related Software (draft guidance)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-9-23

Product Type

Drug

Topic

Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-9-23

Product Type

Drug

Topic

Considerations for the Conduct of Clinical Trials of Medical Products During Major Disruptions Due to Disasters and Public Health Emergencies

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-9-23

Product Type

Biologics

Topic

Labeling for Biosimilar and Interchangeable Biosimilar Products Guidance for Industry (draft guidance)

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

1-9-23

Product Type

Medical Device

Topic

Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-9-23

Product Type

Drug

Topic

Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

New Zealand

Date of Publishing

1-9-23

Product Type

Drug

Topic

Guidelines on the Regulation of Therapeutic Products in New Zealand

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

30-8-23

Product Type

Drug

Topic

Product Information inserts are no longer required for injectable medicines administered by health professionals

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

29-8-23

Product Type

Drug

Topic

Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (draft guidance)

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

29-8-23

Product Type

Medical Device

Topic

Three new UK Approved Bodies to certify medical devices announced by the MHRA

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

25-8-23

Product Type

Medical Device

Topic

Feedback from Australian Sponsors about the Medical Device Single Audit Program (MDSAP)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

24-8-23

Product Type

Drug

Topic

Nitrosamine impurities in medicines - Information for sponsors and manufacturers

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

24-8-23

Product Type

Drug

Topic

Nitrosamines impurities in medicines

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

17-8-23

Product Type

Drug

Topic

New reporting requirements for medicine shortages

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

16-8-23

Product Type

Drug

Topic

EMA review of data on paternal exposure to valproate

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

10-8-23

Product Type

Medical Device

Topic

TEAM-NB Position Paper New MDR Transition Timelines and Notified Body Capacity

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

9-8-23

Product Type

Drug

Topic

Swissmedic gains accreditation for GMP/GDP inspections in the field of ATMPs

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

7-8-23

Product Type

Drug

Topic

Guidance to applicants /Marketing Authorization Holders (MAHs) on oral explanations at EMA

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-8-23

Product Type

Medical Device

Topic

Food and Drug Administration Modernization Act of 1997: Modifications to the List of Recognized Standards, Recognition List Number

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

1-8-23

Product Type

Drug

Topic

FAQS on implementation of GSR 823(e) dated 17th November, 2022 with respect to bar code or QR code on top 300 brands

Domain

URL

Country/Region

UK

Date of Publishing

1-8-23

Product Type

Medical Device

Topic

CE marking recognition for medical devices and in vitro diagnostics

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-8-23

Product Type

Medical Device

Topic

Wearable medical device – Guidance document

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-8-23

Product Type

Medical Device

Topic

Importation of medical device for personal use

Domain

Regulatory

URL

Country/Region

Japan

Date of Publishing

1-8-23

Product Type

Drug

Topic

Points to be Consider for Informed Consent Using Electromagnetic Means in Clinical Trials and Post-marketing Clinical Trials

Domain

Clinical

URL

Country/Region

Japan

Date of Publishing

1-8-23

Product Type

Drug

Topic

Update on nitrosamine contamination

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-8-23

Product Type

Drug

Topic

Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-8-23

Product Type

Drug

Topic

Fixed-Combinations and Single-Entity Versions of Previously Approved Antiretrovirals for the Treatment or Prevention of HIV-1 Under PEPFAR

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-8-23

Product Type

Drug

Topic

PDUFA Waivers, Reductions, and Refunds for FixedCombinations and Single-Entity Versions of Previously Approved Antiretrovirals under PEPFAR (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-8-23

Product Type

Drug

Topic

Classification Categories for Certain Supplements Under BsUFA III (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-8-23

Product Type

Drug

Topic

Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-8-23

Product Type

Drug

Topic

Post marketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-8-23

Product Type

Drug

Topic

Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-8-23

Product Type

Drug

Topic

Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act — Compliance Policies

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

1-8-23

Product Type

Medical Device

Topic

CE marking recognition for medical devices and in vitro diagnostics

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

1-8-23

Product Type

Drug

Topic

FAQS ON IMPLEMENTATION OF GSR 823(E) DATED 17TH NOVEMBER, 2022 WITH RESPECT TO BAR CODE OR QR CODE ON TOP 300 BRANDS

Domain

Labeling

URL

Country/Region

The Philippines

Date of Publishing

1-8-23

Product Type

Drug

Topic

Draft for Comments || Application Process and Requirements for Post-Approval Changes of Biological Products Adopting the World Health Organization Guidelines for Changes to Approved Vaccines and Biotherapeutic Products for Human Use

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-7-23

Product Type

Medical Device

Topic

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder (draft guidance)

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

27-7-23

Product Type

Drug

Topic

MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-7-23

Product Type

Medical Device

Topic

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

26-7-23

Product Type

Drug

Topic

Questions and Answers (Q&As) on the External Guidance on the implementation of the European Medicines Agency policy on the publication of clinical data for medicinal products for human use

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

25-7-23

Product Type

Drug

Topic

Commission acts to accelerate phasing out of animal testing in response to a European Citizens' Initiative

Domain

Non-Clinical

URL

Country/Region

USA

Date of Publishing

24-7-23

Product Type

Drug

Topic

CDRH Announces New Standards Recognition to Support Innovation in Medical Device Sterilization

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

24-7-23

Product Type

Drug

Topic

N-nitrosamine impurities in Ph. Eur. monographs: update on approach

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

20-7-23

Product Type

Drug

Topic

Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

17-7-23

Product Type

Medical Device

Topic

Qualification of Medical Device Development Tools

Domain

Quality

URL

Country/Region

USA

Date of Publishing

10-7-23

Product Type

Medical Device

Topic

Electronic Export Documents – Letter to Industry

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

10-7-23

Product Type

Drug

Topic

Post marketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (draft guidance)

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

10-7-23

Product Type

Medical Device

Topic

Medical devices – single identifier for similar highly individualized devices

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

5-7-23

Product Type

Drug

Topic

Nitrosamine impurities in medicinal products: Swissmedic sets up specialist group

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-7-23

Product Type

Biologics

Topic

Manufacturing Changes and Comparability for Human Cellular and Gene Therapy Products (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-7-23

Product Type

Drug

Topic

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-7-23

Product Type

Drug

Topic

Understanding CDER’s Risk-Based Site Selection Model

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

3-7-23

Product Type

Drug

Topic

WHO Guidance for best practices for clinical trials Draft for public consultation

Domain

Clinical

URL

Country/Region

International

Date of Publishing

3-7-23

Product Type

Drug

Topic

Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

3-7-23

Product Type

Drug

Topic

International Harmonisation of Real-World Evidence Terminology and Convergence of General Principles Regarding Planning and Reporting of Studies Using Real-World Data, with a Focus on Effectiveness of Medicines

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

3-7-23

Product Type

Drug

Topic

Rules and Regulations on the Issuance of Authorization for Registration Applications of Drug Products and Drug Substances by the Food and Drug Administration (draft guidance)

Domain

Regulatory

URL

Country/Region

Singapore

Date of Publishing

3-7-23

Product Type

Drug

Topic

Public consultation on the proposed regulation for active ingredients under the health products act

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

29-6-23

Product Type

Drug

Topic

Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development (draft guidance)

Domain

Clinical

URL

Country/Region

UK

Date of Publishing

16-6-23

Product Type

Medical Device

Topic

Great Britain to accept European CE marks until June 2030 to ensure continued supply

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

31-5-23

Product Type

Drug

Topic

Progress with EU-US mutual recognition agreement for inspections for veterinary medicines

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

30-5-23

Product Type

Medical Device

Topic

FDA Proposes New, Easy-to-Read Medication Guide for Patients, Patient Medication Information

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

26-5-23

Product Type

Medical Device

Topic

New regulatory pathway set to support safe patient access to innovative medical technologies

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

24-5-23

Product Type

Medical Device

Topic

Template for NB - Confirmation letter in the framework of Regulation (EU) 2023/607

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

22-5-23

Product Type

Medical Device

Topic

Send and Track Medical Device Premarket Submissions Online: CDRH Portal

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

19-5-23

Product Type

Drug

Topic

Good Clinical Practice (GCP) E6(R3) (draft guidance)

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

17-5-23

Product Type

Drug

Topic

GMP Clearance: Extension processing times

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

15-5-23

Product Type

Drug

Topic

Guidance for manufacturers on reporting adverse incidents involving Software as a Medical Device under the vigilance system

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

12-5-23

Product Type

Medical Device

Topic

Supply and Shortages of Medical Devices: Frequently Asked Questions

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

12-5-23

Product Type

Medical Device

Topic

Medical Device Supply Chain and Shortages

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

11-5-23

Product Type

Drug

Topic

New safety warning for medicines used in arthritis and other inflammatory conditions

Domain

Safety

URL

Country/Region

USA

Date of Publishing

11-5-23

Product Type

Drug

Topic

FDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions

Domain

Safety

URL

Country/Region

USA

Date of Publishing

11-5-23

Product Type

Drug

Topic

Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products; Availability

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

10-5-23

Product Type

Vaccine

Topic

EMA and European medicines regulatory network lift COVID-19 business continuity status

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

8-5-23

Product Type

Drug

Topic

Commission guidance on the content and structure of the summary of the clinical investigation report

Domain

Clinical

URL

Country/Region

The Philippines

Date of Publishing

5-5-23

Product Type

Drug

Topic

Adoption of the World Health Organization Updated Guidelines on the Evaluation of Similar Biotherapeutic Products (SBPs) in Compliance with Administrative Order No. 2014-0016

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

5-5-23

Product Type

Medical Device

Topic

EU MDR transition extension

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

4-5-23

Product Type

Drug

Topic

Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities in Human Drug Products; Establishment of a Public Docket; Request for Comments

Domain

Safety

URL

Country/Region

Australia

Date of Publishing

3-5-23

Product Type

Drug

Topic

TGA makes final decision to reduce paracetamol pack sizes

Domain

Packaging

URL

Country/Region

Europe

Date of Publishing

3-5-23

Product Type

Drug

Topic

Interim guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS) version 1.0

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

3-5-23

Product Type

Drug

Topic

Review of transparency rules for the EU Clinical Trials Information System (CTIS)

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

1-5-23

Product Type

Drug

Topic

Changes to the forms for new authorizations of and variations to human and veterinary medicinal products

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

1-5-23

Product Type

Drug

Topic

Changes to the guidance document GMP compliance by foreign manufacturers and the form Declaration by the Responsible Person for foreign manufacturers

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

1-5-23

Product Type

Drug

Topic

Guidelines for the Importation and Exportation of Finished Drug Products and Raw Materials (draft guidance)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-5-23

Product Type

Drug

Topic

Antibiotics shortage update and substitution allowed to address shortage of Cefaclor

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-5-23

Product Type

Drug

Topic

Electronic product information (ePI)

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

1-5-23

Product Type

Medical Device

Topic

Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regards to devices covered by certificates according to MDD or AIMDD

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and other High-Risk Drug Components for Diethylene Glycol and Ethylene Glycol

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Diabetes Mellitus: Efficacy Endpoints for Clinical Trials Investigating Antidiabetic Drugs and Biological Products (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biological Products

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers

Domain

Non-Clinical

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Generally Accepted Scientific Knowledge in Applications for Drug and Biological Products: Nonclinical Information (draft guidance)

Domain

Non-Clinical

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Pediatric Drug Development: Regulatory Considerations — Complying With the Pediatric Research Equity Act and Qualifying for Pediatric Exclusivity Under the Best Pharmaceuticals for Children Act

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Q9(R1) Quality Risk Management

Domain

Quality

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Decentralized Clinical Trials for Drugs, Biological Products, and Devices (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-5-23

Product Type

Drug

Topic

S12 Nonclinical Biodistribution Considerations for Gene Therapy Products

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

27-4-23

Product Type

Patents

Topic

Intellectual property: harmonised EU patent rules boost innovation, investment, and competitiveness in the Single Market

Domain

Intellectual property (IP)

URL

Country/Region

Europe

Date of Publishing

26-4-23

Product Type

Drug

Topic

Concept paper on revision of the guideline on clinical investigation of medicinal products in the treatment of patients with acute respiratory distress syndrome

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

26-4-23

Product Type

Drug

Topic

Harmonized bioequivalence guideline paves the way for global generic medicine development and access to medicines

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

26-4-23

Product Type

Drug

Topic

Commission proposes pharmaceuticals reform for more accessible, affordable and innovative medicines

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

25-4-23

Product Type

Drug

Topic

Medical Product Alert N°4/2023: Substandard (contaminated) syrup medicines

Domain

Safety

URL

Country/Region

USA

Date of Publishing

24-4-23

Product Type

Drug

Topic

Product-Specific Guidance Meetings Between the Food and Drug Administration and Abbreviated New Drug Applicants Under the Generic Drug User Fee Act (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

21-4-23

Product Type

Drug

Topic

Single-arm trials as pivotal evidence for the authorization of medicines in the EU

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

19-4-23

Product Type

Medical Device

Topic

Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745

Domain

Regulatory

URL

Country/Region

France

Date of Publishing

19-4-23

Product Type

Drug

Topic

data.ansm: An online platform to learn more about adverse drug reactions and stock-outs

Domain

Safety

URL

Country/Region

USA

Date of Publishing

19-4-23

Product Type

Drug

Topic

New developments in regulatory QSAR modeling: a new QSAR model for predicting blood brain barrier permeability

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

18-4-23

Product Type

Vaccine

Topic

Coronavirus (COVID-19) Update: FDA Authorizes Changes to Simplify Use of Bivalent mRNA COVID-19 Vaccines

Domain

Regulatory

URL

Country/Region

Singapore

Date of Publishing

17-4-23

Product Type

Drug

Topic

Industry consultation on Electronic Common Technical Document (eCTD) implementation in Singapore

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

14-4-23

Product Type

Drug

Topic

Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters - Premarket Notification (510(k)) Submissions

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

13-4-23

Product Type

Medical Device

Topic

Announcements on clinical trials with medical devices and performance studies with vitro diagnostic medical devices

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

13-4-23

Product Type

Drug

Topic

FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use

Domain

Safety

URL

Country/Region

USA

Date of Publishing

11-4-23

Product Type

Drug

Topic

EPA Proposes New Standards to Protect Public Health, Reduce Exposure to Ethylene Oxide Pollution

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

10-4-23

Product Type

Drug

Topic

Food and Drug Administration Data and Technology Strategic Plan; Request for Information and Comments

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

6-4-23

Product Type

Medical Device

Topic

Software and Artificial Intelligence (AI) as a Medical Device

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

5-4-23

Product Type

Drug

Topic

Dual labelled medicines begin transition to sole medicine ingredient names soon

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

4-4-23

Product Type

Food & Food Supplement

Topic

Publishes Tolerances for Deltamethrin on Various Agricultural Commodities

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

4-4-23

Product Type

Drug

Topic

New features further strengthen Priority Medicines scheme (PRIME)

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

4-4-23

Product Type

Medical Device

Topic

Post Market Surveillance National Competent Authority Report Exchange Criteria and Report Form

Domain

Pharmacovigilance

URL

Country/Region

Malaysia

Date of Publishing

4-4-23

Product Type

Drug

Topic

An Analysis of Deficiencies Observed During On-Site Good Manufacturing Practice (GMP) Inspections of Local and Foreign Manufacturing Premise of Medicinal Registered Products in the Year 2022

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-4-23

Product Type

Drug

Topic

Clinical Trial Highlights

Domain

Clinical

URL

Country/Region

Malaysia

Date of Publishing

3-4-23

Product Type

Drug

Topic

Guideline on electronic labelling (E-LABELLING) for pharmaceutical products in malaysia

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

3-4-23

Product Type

Medical Device

Topic

Personalized Medical Devices – Production Verification and Validation

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

3-4-23

Product Type

Medical Device

Topic

Principles and Practices for the Cybersecurity of Legacy Medical Devices

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

3-4-23

Product Type

Medical Device

Topic

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

3-4-23

Product Type

Drug

Topic

Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk M7(R2)

Domain

Clinical

URL

Country/Region

International

Date of Publishing

3-4-23

Product Type

Drug

Topic

Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes - Addendum to M7(R2)

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

3-4-23

Product Type

Drug

Topic

Health Technology Assessment Policy and Methods Review Consultation 1 Survey Questions

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-4-23

Product Type

Medical Device

Topic

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-4-23

Product Type

Medical Device

Topic

Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions (draft guidance

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-4-23

Product Type

Drug

Topic

Mpox: Development of Drugs and Biological Products (draft guidance)

Domain

Clinical

URL

Country/Region

The Philippines

Date of Publishing

1-4-23

Product Type

Medical Device

Topic

Guidelines on the Regulatory Flexibility for Class B, C and D Medical Devices that are Not Included in the List of Registrable Medical Devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-4-23

Product Type

Drug

Topic

Acute Radiation Syndrome: Developing Drugs for Prevention and Treatment (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-4-23

Product Type

Drug

Topic

Over-the-Counter Monograph Order Requests (OMORs): Format and Content (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-4-23

Product Type

Drug

Topic

Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-4-23

Product Type

Drug

Topic

Assessing Adhesion with Transdermal and Topical Delivery (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-4-23

Product Type

Drug

Topic

A Risk-Based Approach to Monitoring of Clinical Investigations

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-4-23

Product Type

Drug

Topic

Notifying FDA of a Discontinuance or Interruption in Manufacturing of Finished Products or Active Pharmaceutical Ingredients Under Section 506C of the FD&C Act (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-4-23

Product Type

Drug

Topic

Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision-Making (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

31-3-23

Product Type

Drug

Topic

Regulatory information – adjusted fees for applications to EMA from 1 April 2023

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

30-3-23

Product Type

Drug

Topic

Guideline on influenza vaccines – submission and procedural requirements

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

30-3-23

Product Type

Drug

Topic

EMA GCP IWG points to consider regarding the management of ongoing clinical trials impacted by political conflicts, natural disasters, or other major disruptions

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

30-3-23

Product Type

Medical Device

Topic

Questions and answers on data requirements when replacing hydrofluorocarbons as propellants in oral pressurized metered dose inhalers

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

30-3-23

Product Type

Medical Device

Topic

Medical Device Development Tools (MDDT)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

30-3-23

Product Type

Medical Device

Topic

Cybersecurity in Medical Devices: Refuse to Accept Policy for Cyber Devices and Related Systems Under Section 524B of the FD&C Act

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

29-3-23

Product Type

Vaccine

Topic

Substitution of in-vivo Method(s) by in-vitro Method(s) for the Quality Control of Vaccines

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

29-3-23

Product Type

Medical Device

Topic

MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

29-3-23

Product Type

Medical Device

Topic

Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions (draft guidance)

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

28-3-23

Product Type

Medical Device

Topic

Extension of CE certificates

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-3-23

Product Type

Medical Device

Topic

General Considerations for Animal Studies Intended to Evaluate Medical Devices

Domain

Safety

URL

Country/Region

Switzerland

Date of Publishing

27-3-23

Product Type

Medical Device

Topic

Findings on manufacturers failing to meet post market surveillance requirements

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-3-23

Product Type

Drug

Topic

Update on In-Person Face-to-Face ANDA Meetings

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-3-23

Product Type

Medical Device

Topic

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-3-23

Product Type

Medical Device

Topic

Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

24-3-23

Product Type

Drug

Topic

TGA’s new powers will help reduce the impact of medicine shortages on patients

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

23-3-23

Product Type

Medical Device

Topic

Withdrawal of medical device registration (new and re-register) and change of notification application

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

21-3-23

Product Type

Drug

Topic

Consultation outcome - Government response to consultation on legislative proposals for clinical trials

Domain

Clinical

URL

Country/Region

UK

Date of Publishing

21-3-23

Product Type

Drug

Topic

MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

20-3-23

Product Type

Drug

Topic

GMP Clearance: Additional countries added to MRA pathway

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

20-3-23

Product Type

Medical Device

Topic

Request for an update of the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates, which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties

Domain

Safety

URL

Country/Region

Malaysia

Date of Publishing

17-3-23

Product Type

Drug

Topic

Topiramate: Neurodevelopmental disorders in children exposed to topiramate during pregnancy

Domain

Regulatory

URL

Country/Region

Argentina

Date of Publishing

16-3-23

Product Type

Drug

Topic

ANMAT signed a Memorandum of Understanding with the United States Pharmacopoeia

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

16-3-23

Product Type

Drug

Topic

Pharmacogenomic Data Submissions (draft guidance)

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

13-3-23

Product Type

Drug

Topic

Declaration of Worldwide Registration Status for Generic Medicines in QUEST System

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

10-3-23

Product Type

Drug

Topic

Evaluation of Gastric pH Dependent Drug Interactions with Acid-Reducing Agents: Study Design, Data Analysis, and Clinical Implications

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

9-3-23

Product Type

Drug

Topic

Guideline on computerized systems and electronic data in clinical trials

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

8-3-23

Product Type

Medical Device

Topic

Classification of rehabilitation, physiotherapy, and speech therapy device

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

8-3-23

Product Type

Medical Device

Topic

Amendment of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (MDR)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

8-3-23

Product Type

Medical Device

Topic

Amendment of Regulation (EU) 2017/746 of the European Parliament and of the Council as regards the frequency of complete re-assessments of notified bodies (IVDR)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

7-3-23

Product Type

Medical Device

Topic

Council takes action to mitigate risk of medical devices shortage y extending the MDR deadlines

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

7-3-23

Product Type

Drug

Topic

Questions and Answers about the raw data proof-of-concept pilot for industry

Domain

Clinical

URL

Country/Region

UK

Date of Publishing

7-3-23

Product Type

Medical Device

Topic

Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

7-3-23

Product Type

Drug

Topic

Nitrosamine Impurities: Latest USP Tool Further Aids Understanding and Control

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

6-3-23

Product Type

Food & Food Supplement

Topic

FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements

Domain

Safety

URL

Country/Region

The Philippines

Date of Publishing

6-3-23

Product Type

Drug

Topic

Guidelines on Regulatory Reliance on the Conduct of Clinical Trials

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

4-3-23

Product Type

Medical Device

Topic

Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-3-23

Product Type

Drug

Topic

European Pharmacopoeia Commission creates new Excipients Strategy Working Party

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-3-23

Product Type

Drug

Topic

Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for Industry

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

1-3-23

Product Type

Drug

Topic

WHO Good Manufacturing Practices for excipients used in pharmaceutical products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-23

Product Type

Drug

Topic

Research Involving Children as Subjects and Not Otherwise Approvable by an IRB: Process for Referrals to FDA and OHRP (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-3-23

Product Type

Medical Device

Topic

Identification of Medicinal Products — Implementation and Use

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

1-3-23

Product Type

Drug

Topic

New Mobile technologies guidance document for human and veterinary medicinal products

Domain

Packaging

URL

Country/Region

Europe

Date of Publishing

1-3-23

Product Type

Medical Device

Topic

Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure (CECP)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-3-23

Product Type

Drug

Topic

Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-3-23

Product Type

Drug

Topic

Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-23

Product Type

Drug

Topic

Development of Local Anesthetic Drug Products with Prolonged Duration of Effect

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-3-23

Product Type

Medical Device

Topic

Total Product Life Cycle Advisory Program (TAP)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-3-23

Product Type

Drug

Topic

Discussion Paper: Artificial Intelligence in Drug Manufacturing, Notice; Request for Information and Comments

Domain

Pharmacovigilance

URL

Country/Region

Malaysia

Date of Publishing

28-2-23

Product Type

Medical Device

Topic

Notification of custom-made medical device

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-2-23

Product Type

Drug

Topic

CDER Continues to Advance Rare Disease Drug Development with New Efforts, Including the Accelerating Rare Disease Cures (ARC) Program

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

27-2-23

Product Type

Drug

Topic

Windsor Framework unveiled to fix problems of the Northern Ireland Protocol

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-23

Product Type

Drug

Topic

Question and Answer on the submission of applications for the expert panels’ advice to manufacturers

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

9-2-23

Product Type

Drug

Topic

Questions and answers – Clinical Trials Information System (CTIS) and Clinical Trials Regulation (CTR)

Domain

Clinical

URL

Country/Region

International

Date of Publishing

7-2-23

Product Type

Medical Device

Topic

IMDRF Terms of Reference

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-2-23

Product Type

Medical Device

Topic

Changes to medical device essential principles for nanomaterials

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

31-1-23

Product Type

Medical Device

Topic

Surveying, Leveling, and Alignment Laser Products

Domain

Regulatory

URL

Country/Region

Mexico

Date of Publishing

25-1-23

Product Type

Drug

Topic

Mexico proposes a Latin American Medicines Agency for health self-sufficiency

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

20-1-23

Product Type

Medical Device

Topic

Gastroenterology-Urology Devices; Classification of the Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

20-1-23

Product Type

Medical Device

Topic

Ophthalmic Devices; Classification of the Intense Pulsed Light Device for Managing Dry Eye

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

20-1-23

Product Type

Medical Device

Topic

Radiological Health Regulations: Amendments to Records and Reports for Radiation Emitting Electronic Products; Amendments to Performance Standards for Diagnostic X-ray, Laser, and Ultrasonic Products

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

13-1-23

Product Type

Medical Device

Topic

Requirements for application of Certificate Of Free Sale (CFS), Manufacturing Certificate (MC) and Certificate Of Free Sale For Export only (CFS EO) medical devices (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

6-1-23

Product Type

Medical Device

Topic

More time to certify medical devices under MDR to mitigate risks of shortages

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-1-23

Product Type

Drug

Topic

Coordination of pharmacovigilance inspections

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

3-1-23

Product Type

Medical Device

Topic

List of standard fees

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-1-23

Product Type

Drug

Topic

Pharmeuropa 35.1 just released

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-1-23

Product Type

Drug

Topic

Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases (draft guidance)

Domain

Clinical

URL

Country/Region

Malaysia

Date of Publishing

1-1-23

Product Type

Medical Device

Topic

Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation

Domain

Regulatory

URL

Country/Region

The Netherlands

Date of Publishing

1-1-23

Product Type

Drug

Topic

Changes to fees for human medicinal products and devices as of 1 January 2023

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

23-12-22

Product Type

Drug

Topic

FDA alerts drug manufacturers to the risk of benzene contamination in certain drugs

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

22-12-22

Product Type

Drug

Topic

Controlled Correspondence Related to Generic Drug Development (draft guidance)

Domain

Regulatory

URL

Country/Region

Ireland

Date of Publishing

20-12-22

Product Type

Drug

Topic

Bioequivalence for immediate release solid oral dosage forms M13A

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

20-12-22

Product Type

Medical Device

Topic

Exemptions, Variances, and Alternative Forms of Adverse Event Reporting for Medical Devices

Domain

Safety

URL

Country/Region

International

Date of Publishing

19-12-22

Product Type

Medical Device

Topic

IMDRF Standard Operating Procedures - Edition 8

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

16-12-22

Product Type

Drug

Topic

EMA Management Board: highlights of December 2022 meeting

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

16-12-22

Product Type

Medical Device

Topic

Guidance on Periodic Safety Update Report (PSUR) according to regulation (EU) 2017/745 (MDR)

Domain

Safety

URL

Country/Region

USA

Date of Publishing

15-12-22

Product Type

Drug

Topic

Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

15-12-22

Product Type

Drug

Topic

Guidance for Industry Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection (draft guidance)

Domain

Regulatory

URL

Country/Region

Singapore

Date of Publishing

14-12-22

Product Type

Drug

Topic

Mean applicant screening response time

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

14-12-22

Product Type

Drug

Topic

FDA approves updated drug labeling including new indications and dosing regimens for capecitabine tablets under Project Renewal

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

14-12-22

Product Type

Drug

Topic

Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

14-12-22

Product Type

Medical Device

Topic

Substantial modification of performance study under Regulation (EU) 2017/746

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

13-12-22

Product Type

Drug

Topic

Inspections/Audits of Pharmacovigilance (PV) system of importers and manufacturers of human vaccine

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

13-12-22

Product Type

Drug

Topic

Commission proposes updated EMA fees

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

9-12-22

Product Type

Drug

Topic

Pulmonary Tuberculosis: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

9-12-22

Product Type

Drug

Topic

Safety advisory - Low levels of contamination with N-nitroso-quinapril

Domain

Safety

URL

Country/Region

USA

Date of Publishing

9-12-22

Product Type

Medical Device

Topic

Content of Human Factors Information in Medical Device Marketing Submissions (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

9-12-22

Product Type

Drug

Topic

CMC Reviews of Type III DMFs for Packaging Materials

Domain

Packaging

URL

Country/Region

USA

Date of Publishing

9-12-22

Product Type

Drug

Topic

Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

9-12-22

Product Type

Medical Device

Topic

Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

8-12-22

Product Type

Drug

Topic

Acceptability of Standards from Alternative Compendia (BP/EP/JP)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

8-12-22

Product Type

Medical Device

Topic

MDCG position paper on ‘hybrid audits’

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

7-12-22

Product Type

Drug

Topic

Changes to pharmaceutical database based on feedback received

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

7-12-22

Product Type

Medical Device

Topic

Augmented Reality and Virtual Reality in Medical Devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

7-12-22

Product Type

Drug

Topic

Product Quality Microbiology Information in the Common Technical Document - Quality (CTD-Q)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

6-12-22

Product Type

Medical Device

Topic

Proposal to delay the implementation of the Medical Device Regulation

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

6-12-22

Product Type

Drug

Topic

Homeopathic Drug Products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

5-12-22

Product Type

Drug

Topic

E19 A selective approach to safety data collection in specific late-stage preapproval or post-approval clinical trials

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

5-12-22

Product Type

Drug

Topic

Statistical Approaches to Establishing Bioequivalence (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

2-12-22

Product Type

Medical Device

Topic

Regulations to lay down common specifications and rules for reclassification of products without an intended medical purpose under the Medical Devices Regulation (MDR)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

2-12-22

Product Type

Drug

Topic

EMA recommends withdrawal of pholcodine medicines from EU market

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-12-22

Product Type

Drug

Topic

ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions (draft guidance)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

30-11-22

Product Type

Drug

Topic

A warning that advertising Ozempic (semaglutide) is prohibited

Domain

Labeling

URL

Country/Region

Ireland

Date of Publishing

28-11-22

Product Type

Drug

Topic

Update on review of over-the-counter medicines containing codeine.

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

21-11-22

Product Type

Medical Device

Topic

Change notification for registered medical device

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

21-11-22

Product Type

Drug

Topic

NMPA Announcement on putting into use the electronic certificates of Documentation for Export of APIs to EU and Certificate of a Pharmaceutical Product

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

17-11-22

Product Type

Drug

Topic

Upcoming Product-Specific Guidances for Generic Drug Product Development

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

16-11-22

Product Type

Drug

Topic

Continuous manufacturing of drug substances and drug products Q13

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

14-11-22

Product Type

Medical Device

Topic

Referencing the Definition of “Device” in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents

Domain

Regulatory

URL

Country/Region

Indonesia

Date of Publishing

9-11-22

Product Type

Drug

Topic

Explanation of BPOM RI number HM.01.1.2.11.22.178 dated 9 November 2022 regarding development of results of supervision of drug syrup and procedure of propylene glycol raw materials containing contaminants EG and DEG exceed the limits

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

9-11-22

Product Type

Medical Device

Topic

Notification of custom-made medical device - Guidance document

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

8-11-22

Product Type

Drug

Topic

Submission of Suspected Unexpected Serious Adverse Reactions reports using ICSR submissions or MHRA gateway

Domain

Safety

URL

Country/Region

Australia

Date of Publishing

7-11-22

Product Type

Drug

Topic

International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names

Domain

Labeling

URL

Country/Region

UK

Date of Publishing

7-11-22

Product Type

Biologics

Topic

Guidance on the licensing of biosimilar products

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

7-11-22

Product Type

Drug

Topic

International harmonisation of ingredient names (IHIN) – Dual labelling transition to sole medicine ingredient names

Domain

Labeling

URL

Country/Region

UK

Date of Publishing

7-11-22

Product Type

Biologics

Topic

Guidance on the licensing of biosimilar products

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

4-11-22

Product Type

Drug

Topic

Changes to the Guidance document Variations TAM HMV4

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

4-11-22

Product Type

Drug

Topic

Changes to the Guidance document Variations TAM HMV4

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-11-22

Product Type

Drug

Topic

Regulatory update - EMA encourages companies to submit type I variations for 2022 by end of November

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

3-11-22

Product Type

Medical Device

Topic

Post-market review of spinal cord stimulation (SCS) devices

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

3-11-22

Product Type

Drug

Topic

Regulatory update - EMA encourages companies to submit type I variations for 2022 by end of November

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

3-11-22

Product Type

Medical Device

Topic

Post-market review of spinal cord stimulation (SCS) devices

Domain

Pharmacovigilance

URL

Country/Region

The Philippines

Date of Publishing

1-11-22

Product Type

Drug

Topic

Guidelines Prescribing the Principle of Reliance for Regulatory Decisions of the Food and Drug Administration

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

1-11-22

Product Type

Drug

Topic

Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National Public Health Emergencies

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Drug

Topic

Sameness Evaluations in an ANDA — Active Ingredients (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Biologics

Topic

Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Drug

Topic

M10 Bioanalytical method validation and study sample analysis

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Drug

Topic

Sameness Evaluations in an ANDA — Active Ingredients (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Biologics

Topic

Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Drug

Topic

M10 Bioanalytical method validation and study sample analysis

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Drug

Topic

Cross Labeling Oncology Drugs in Combination Regimens

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Drug

Topic

S1B(R1) Addendum to S1B Testing for Carcinogenicity of Pharmaceuticals

Domain

Non-Clinical

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Biologics

Topic

Studying Multiple Versions of a Cellular or Gene Therapy Product in an Early-Phase Clinical Trial

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-11-22

Product Type

Drug

Topic

Expanded Access to Investigational Drugs for Treatment Use Questions and Answers (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

31-10-22

Product Type

Drug

Topic

Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement - updated on 10/31/2022

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

28-10-22

Product Type

Drug

Topic

The Council of Europe/EDQM and the European Union conclude an agreement expanding the scope of their co-operation in the field of substances of human origin

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

27-10-22

Product Type

Drug

Topic

IPC's Notice Regarding General Chapters of IP 2022

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

27-10-22

Product Type

Drug

Topic

IPC's Notice Regarding General Chapters of IP 2022

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-10-22

Product Type

Drug

Topic

Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

26-10-22

Product Type

Drug

Topic

Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

25-10-22

Product Type

Medical Device

Topic

Implementation of the Future Regulations

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

25-10-22

Product Type

Drug

Topic

In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

25-10-22

Product Type

Drug

Topic

Human Gene Therapy for Neurodegenerative Diseases

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

24-10-22

Product Type

Drug

Topic

Information about the raw data proof-of-concept pilot for industry

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

21-10-22

Product Type

Drug

Topic

In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

21-10-22

Product Type

Drug

Topic

Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

21-10-22

Product Type

Drug

Topic

Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (draft guidance)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

21-10-22

Product Type

Drug

Topic

GMP Clearance: Temporary changes to target processing times

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

21-10-22

Product Type

Medical Device

Topic

Select Updates for the Breakthrough Devices Program Guidance: Reducing Disparities in Health and Health Care (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

20-10-22

Product Type

Drug

Topic

Multiple Endpoints in Clinical Trials

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

19-10-22

Product Type

Drug

Topic

Advancing Real-World Evidence Program

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

18-10-22

Product Type

Drug

Topic

Anonymization of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6)

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

18-10-22

Product Type

Drug

Topic

Anonymization of Protected Personal Data and assessment of Commercially Confidential Information during the preparation of RMPs (main body and annexes 4 and 6)

Domain

Pharmacovigilance

URL

Country/Region

UK

Date of Publishing

17-10-22

Product Type

Medical Device

Topic

Software and AI as a Medical Device Change Programme - Roadmap

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

17-10-22

Product Type

Drug

Topic

Complex Generics News

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

14-10-22

Product Type

Drug

Topic

European Medicines Agency Guidance for Applicants seeking scientific advice and protocol assistance

Domain

Clinical

URL

Country/Region

India

Date of Publishing

11-10-22

Product Type

Medical Device

Topic

EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

5-10-22

Product Type

Drug

Topic

Prioritization of the Review of Original ANDAs, Amendments, and Supplements

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

5-10-22

Product Type

Drug

Topic

Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

5-10-22

Product Type

Drug

Topic

Information Requests and Discipline Review Letters Under GDUFA

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

5-10-22

Product Type

Drug

Topic

Post-Complete Response Letter Clarification Teleconferences Between FDA and ANDA Applicants Under GDUFA

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

5-10-22

Product Type

Drug

Topic

Competitive Generic Therapies

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-22

Product Type

Drug

Topic

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-22

Product Type

Drug

Topic

Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-10-22

Product Type

Medical Device

Topic

Guidance on Authorized Representatives Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-22

Product Type

Drug

Topic

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA (Draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-22

Product Type

Medical Device

Topic

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-22

Product Type

Medical Device

Topic

FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-22

Product Type

Medical Device

Topic

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-22

Product Type

Drug

Topic

Facility Readiness: Goal Date Decisions Under GDUFA (Draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-10-22

Product Type

Drug

Topic

Split Real Time Application Review (STAR)

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

27-9-22

Product Type

Drug

Topic

Clinical electronic structured harmonized protocol (CESHARP) M11

Domain

Clinical

URL

Country/Region

The Philippines

Date of Publishing

27-9-22

Product Type

Medical Device

Topic

Abridged Processing of Application for Registration of Medical Devices Approved by the National Regulatory Authority of Any ASEAN Member Country

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

10-8-22

Product Type

Medical Device

Topic

MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

4-8-22

Product Type

Drug

Topic

itrosamines – Deadline extension for all CEP holders to complete step 3 Revision to the CEP (now 1 October 2023)

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

4-8-22

Product Type

Medical Device

Topic

Classification of medical devices pertaining to rehabilitation under the provisions of Medical Devices rule

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

4-8-22

Product Type

Medical Device

Topic

Classification of medical devices pertaining to rehabilitation under the provisions of Medical Devices rule

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

29-7-22

Product Type

Medical Device

Topic

MDCG 2022-13 - Designation, re-assessment and notification of conformity assessment bodies and notified bodies

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

29-7-22

Product Type

Medical Device

Topic

Price control on medical devices

Domain

Regulatory

URL

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