Back to Main Menu
social link
social link
social link

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.


Filter
Country/Region Health Authority Date of Publishing Product Type Topic Domain URL
USA Food and Drug Administration 28-6-23 Medical Device Patient-Matched Guides to Orthopedic Implants (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 28-6-23 Medical Device CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies Regulatory Visit Page
USA Food and Drug Administration 27-6-23 Drug Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests Regulatory Visit Page
USA Food and Drug Administration 23-6-23 Drug Migraine: Developing Drugs for Preventive Treatment (draft guidance) Clinical Visit Page
Global INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE 20-6-23 Drug ICH press release Regulatory Visit Page
USA Food and Drug Administration 20-6-23 Drug Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program Regulatory Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 19-6-23 Drug Revised Policy document PA/PH/CEP (04) 1, 7R on Content of the CEP dossier released for public consultation Regulatory Visit Page
Argentina ANMAT 16-6-23 Drug Argentina, Brazil and Chile enter the dialogue for the integration of an international health agency Regulatory 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
Switzerland The Swiss Agency for Therapeutic Products 15-6-23 Drug https://www.swissmedic.ch/swissmedic/en/home/kpa/aktuell-kpa/anpassung-wl-homoeopathika-anthroposophika-weitere-kpa.html Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 15-6-23 Drug 150-day assessment for national applications for medicines Regulatory Visit Page
USA Food and Drug Administration 14-6-23 Medical Device Content of Premarket Submissions for Device Software Functions Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 9-6-23 Drug Centrally Authorised Products (CAPs) Bridging Mechanism Regulatory Visit Page
USA Food and Drug Administration 6-6-23 Drug FDA Announces Additional Steps to Modernize Clinical Trials Clinical Visit Page
USA Food and Drug Administration 5-6-23 Drug Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment Non-Clinical Visit Page
USA Food and Drug Administration 5-6-23 Drug Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals Non-Clinical Visit Page
Australia Therapeutic Goods Administration 2-6-23 Drug TGA supports MHRA’s new international recognition framework for medicines Regulatory Visit Page
USA Food and Drug Administration 2-6-23 Medical Device Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Regulatory Visit Page
Singapore Health Sciences Authority 1-6-23 Medical Device HSA's SRA status for in vitro diagnostic medical devices (IVD) Regulatory Visit Page
Europe European Medicines Agency 1-6-23 Drug Digital therapeutics which could help transform patient care available only in a limited number of European countries Regulatory Visit Page
Europe European Medicines Agency 1-6-23 Drug Real-world evidence framework to support EU regulatory decision-making Regulatory Visit Page
The Philippines Philippines FDA 1-6-23 Drug Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System (draft for comments) Labeling Visit Page
The Philippines Philippines FDA 1-6-23 Drug and Biological Product Public Consultation on the Proposed Guidelines on the Regulation of Stem Cell Facilities Regulatory Visit Page
The Philippines Philippines FDA 1-6-23 Drug Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration (Draft guidance for comments) Regulatory Visit Page
Australia Therapeutic Goods Administration 1-6-23 Medical Device Transition to new manufacturer evidence for IVD medical devices Guidance for manufacturers and sponsors of IVD medical devices Regulatory Visit Page
Australia Therapeutic Goods Administration 1-6-23 Medical Device Consultation on the regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin Regulatory Visit Page
Australia Therapeutic Goods Administration 1-6-23 Drug Oral anticoagulants can cause serious kidney damage in rare circumstances Safety Visit Page
USA Food and Drug Administration 1-6-23 Drug Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements Labeling Visit Page
USA Food and Drug Administration 1-6-23 Drug Psychedelic Drugs: Considerations for Clinical Investigations Clinical Visit Page
USA Food and Drug Administration 1-6-23 Drug Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act Regulatory Visit Page
USA Food and Drug Administration 1-6-23 Drug Assessing User Fees Under the Generic Drug User Fee Amendments of 2022 Regulatory Visit Page
USA Food and Drug Administration 1-6-23 Drug Drug-Drug Interaction Assessment for Therapeutic Proteins Clinical 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
Europe European Food Safety Authority – EFSA 26-5-23 Food & Food Supplement Regulation Scientific opinion on the tolerable upper intake level for vitamin B6 Novel food 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
Global 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
Europe European Food Safety Authority – EFSA 17-5-23 Food & Food Supplement Regulation Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283 Novel food Visit Page
Europe European Food Safety Authority – EFSA 17-5-23 Food & Food Supplement Regulation Scientific opinion on the tolerable upper intake level for vitamin B6 Dietary reference values 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
USA U.S. Government Printing Office (GPO) Food Safety Authority – EFSA 10-5-23 Food & Food Supplement Regulation Cyflufenamid; Pesticide Tolerance, 40 CFR” and “Fomesafen; Pesticide Tolerances, 40 CFR” Pesticides 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
New Zealand New Zealand Medicines and Medical Devices Safety 8-5-23 Drug Review of pholcodine-containing medicines Safety 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
Brazil Brazilian Health Regulatory Agency (Anvisa) 4-5-23 Drug Anvisa updates the rule governing requirements for clinical analysis exams Clinical 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
India Central Drugs Standard Control Organisation 2-5-23 Medical Device Streamlining of medical device regulations Regulatory Visit Page
Singapore Health Sciences Authority 2-5-23 Medical Device Consultation on GN-14 Guidance on the Risk Classification of In Vitro Diagnostic Medical Devices Regulatory 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
Global World Health Organization (WHO) 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
Singapore Singapore Food Agency 18-4-23 Food & Food Supplement Regulation Amends Food Regulations 2023 on Veterinary Drug Residues Veterinary 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 U.S. Government Printing Office (GPO) 4-4-23 Food & Food Supplement Regulation Publishes Tolerances for Deltamethrin on Various Agricultural Commodities Pesticides Visit Page
Europe European Medicines Agency 4-4-23 Drug New features further strengthen Priority Medicines scheme (PRIME) Regulatory Visit Page
Global 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
Bahrain The National Pharmaceutical Regulatory Agency (NPRA) 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
Global International Medical Device Regulators Forum 3-4-23 Medical Device Personalized Medical Devices – Production Verification and Validation Regulatory Visit Page
Global International Medical Device Regulators Forum 3-4-23 Medical Device Principles and Practices for the Cybersecurity of Legacy Medical Devices Regulatory Visit Page
Global International Medical Device Regulators Forum 3-4-23 Medical Device Software and Artificial Intelligence (AI) as a Medical Device Regulatory Visit Page
Global 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
Global 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 Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act Regulatory Visit Page
Japan Pharmaceuticals and Medical Devices Agency 3-4-23 Drug Ministerial Ordinance on Good Clinical Practice for Drugs Clinical 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 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 (IPC) 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 Drug Clinical trial considerations to support accelerated approval of oncology therapeutics (draft guidance) Clinical 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 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
USA Food and Drug Administration 20-3-23 Medical Device Send and Track Medical Device Premarket Submissions Online: CDRH Portal Regulatory 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 Regulation FDA Launches New Directory of Ingredients Used in Products Marketed as Dietary Supplements Ingredient 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
Global World Health Organization (WHO) 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
Europe European Medicines Agency 1-3-23 Medical Device Extension of the MDR transitional period and removal of the ‘sell off’ periods Regulatory 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 Regulatory 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
New Zealand New Zealand Medicines and Medical Devices Safety 27-2-23 Drug Outcome of the consultation on the proposed warning and advisory statements for ocular decongestants for eye redness and/or minor eye irritation Safety Visit Page
Malaysia Medical Device Authority 24-2-23 Medical Device Malaysia MDA introduces new online payment system Regulatory Visit Page
USA Food and Drug Administration 23-2-23 Medical Device Examples of Medical Device Misconnections 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
USA Food and Drug Administration 21-2-23 Drug Press Statement: 21 February 2023 FDA Philippines Launches Task Force Fleming to Make Safe and Effective Covid-19 Drugs More Accessible to All Filipinos Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 20-2-23 Medical Device Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU Regulatory Visit Page
Europe European Medicines Agency 16-2-23 Biologics Adjuvants in vaccines for human use - Scientific guideline Regulatory Visit Page
Europe European Medicines Agency 10-2-23 Drug Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023 Pharmacovigilance 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
USA Food and Drug Administration 9-2-23 Medical Device Medical Device Material Safety Summaries Safety Visit Page
Australia Therapeutic Goods Administration 8-2-23 Drug Avoid prescribing pregabalin in pregnancy if possible Safety Visit Page
USA Food and Drug Administration 8-2-23 Drug Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics Regulatory Visit Page
USA Food and Drug Administration 7-2-23 Drug ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements Regulatory Visit Page
Global International Medical Device Regulators Forum 7-2-23 Medical Device IMDRF Terms of Reference Regulatory Visit Page
Europe European Medicines Agency 6-2-23 Drug Guidance for Stepwise PIP pilot Clinical Visit Page
Europe European Medicines Agency 6-2-23 Drug EFPIA response to EU Commission proposal for revised EMA Fees regulation Regulatory Visit Page
Global International Medical Device Regulators Forum 3-2-23 Medical Device Medical Device Regulatory Review Report: Guidance Regarding Information to be Included Regulatory Visit Page
Europe European Medicines Agency 3-2-23 Drug Public consultation on a multi-stakeholder platform to improve clinical trials in the EU Clinical Visit Page
UK Medicines and Healthcare products Regulatory Agency 3-2-23 Medical Device Medical technology strategy Regulatory Visit Page
Australia Therapeutic Goods Administration 3-2-23 Drug Change to classification of psilocybin and MDMA to enable prescribing by authorized psychiatrists. Regulatory Visit Page
Australia Therapeutic Goods Administration 3-2-23 Drug TGA makes interim decision to reduce maximum paracetamol pack sizes. Regulatory Visit Page
Europe European Medicines Agency 3-2-23 Drug ICH guideline Q9 (R1) on quality risk management Quality Visit Page
USA Food and Drug Administration 3-2-23 Medical Device Total Product Life Cycle Advisory Program (TAP) Regulatory Visit Page
Australia Therapeutic Goods Administration 1-2-23 Medical Device Changes to medical device essential principles for nanomaterials Regulatory Visit Page
Europe European Union 1-2-23 Medical Device Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices Regulatory Visit Page
Europe European Union 1-2-23 Medical Device Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 Regulatory Visit Page
USA Food and Drug Administration 1-2-23 Drug Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-2-23 Drug Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
The Philippines Philippines FDA 1-2-23 Drug Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National or State of Public Health Emergencies (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-2-23 Drug Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development (draft guidance) Clinical Visit Page
USA Food and Drug Administration 1-2-23 Drug Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
USA Food and Drug Administration 1-2-23 Drug Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (draft guidance) Regulatory Visit Page
Europe European Medicines Agency 31-1-23 Drug Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU Clinical Visit Page
USA Food and Drug Administration 31-1-23 Medical Device Surveying, Leveling, and Alignment Laser Products Regulatory Visit Page
Ireland Health Products Regulatory Authority 30-1-23 Drug Fees for Human Products Regulatory Visit Page
USA Food and Drug Administration 27-1-23 Medical Device Health Canada and FDA eSTAR Pilot Regulatory Visit Page
Europe European Medicines Agency 26-1-23 Drug ICH Guideline M13A on bioequivalence for immediate release solid oral dosage forms Clinical Visit Page
Mexico COFEPRIS 25-1-23 Drug Mexico proposes a Latin American Medicines Agency for health self-sufficiency Regulatory Visit Page
Europe European Union 25-1-23 Medical Device Scientific advice pilot for high-risk medical devices device Regulatory Visit Page
USA Food and Drug Administration 24-1-23 Drug Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Guidance for Industry; Availability Clinical Visit Page
UK Medicines and Healthcare products Regulatory Agency 24-1-23 Drug European Commission Decision Reliance Procedure (ECDRP) extension Regulatory Visit Page
Europe European Medicines Agency 23-1-23 Drug Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2023 Pharmacovigilance 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
Europe European Medicines Agency 20-1-23 Drug Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines 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
Europe European Medicines Agency 19-1-23 Drug Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications Clinical Visit Page
USA Food and Drug Administration 17-1-23 Medical Device Classification of the Prognostic Test for Assessment of Liver Related Disease Progression Regulatory Visit Page
USA Food and Drug Administration 13-1-23 Medical Device Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions 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
USA Food and Drug Administration 12-1-23 Medical Device Photobiomodulation (PBM) Devices - 2 Premarket Notification [510(k)] 3 Submissions (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 12-1-23 Medical Device Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 11-1-23 Drug Position paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products Clinical Visit Page
Europe European Union 6-1-23 Medical Device Questions and Answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation Regulatory Visit Page
Europe European Union 6-1-23 Medical Device More time to certify medical devices under MDR to mitigate risks of shortages Regulatory Visit Page
USA Food and Drug Administration 5-1-23 Medical Device Orthopedic Devices; Classification of the Bone Indentation Device Regulatory Visit Page
USA Food and Drug Administration 5-1-23 Medical Device Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device Regulatory Visit Page
USA Food and Drug Administration 5-1-23 Medical Device Neurological Devices; Classification of the Brain Stimulation Programming Planning Software Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 3-1-23 Drug-Device Combination Guideline on the Regulation of Therapeutic Products in New Zealand Regulatory Visit Page
The Philippines Philippines FDA 3-1-23 Drug Updated Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices (draft for comments) Regulatory Visit Page
The Philippines Philippines FDA 3-1-23 Medical Device Guidelines on the Conduct of Regulatory Inspections for Radiation Facilities 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
Switzerland The Swiss Agency for Therapeutic Products 3-1-23 Medical Device MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured Regulatory Visit Page
Malaysia National Pharmaceutical Regulatory Agency 3-1-23 Drug-Device Combination Guideline for drug-medical device and medical device-drug combination products - endorsement letter application - adverse drug reaction and incident reporting Regulatory Visit Page
Europe European Medicines Agency 3-1-23 Drug Pharmeuropa 35.1 just released Regulatory Visit Page
USA Food and Drug Administration 3-1-23 Medical Device Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System 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 How to submit an application for registration of a refurbished medical device Regulatory Visit Page
USA Food and Drug Administration 1-1-23 Drug Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (draft guidance) Labeling Visit Page
Europe European Medicines Agency 1-1-23 Drug Guidance on good manufacturing practice and good distribution practice: Questions and answers Regulatory Visit Page
Europe European Union 1-1-23 Medical Device Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 Regulatory Visit Page
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 1-1-23 Format and Content of a REMS Document Format and Content of a REMS Document Safety Visit Page
USA Food and Drug Administration 30-12-22 Medical Device Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid Regulatory Visit Page
USA Food and Drug Administration 28-12-22 Medical Device Classification of the Interventional Cardiovascular Implant Simulation Software Device Regulatory Visit Page
USA Food and Drug Administration 27-12-22 Medical Device Classification of the Adjunctive Hemodynamic Indicator with Decision Point 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
International 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
Global International Medical Device Regulators Forum 19-12-22 Medical Device IMDRF Standard Operating Procedures 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
UK Medicines and Healthcare products Regulatory Agency 5-12-22 Medical Device Guidance for manufacturers on vigilance Pharmacovigilance 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 Medical Device Requirements for labelling of medical devices Labeling Visit Page
USA Food and Drug Administration 17-11-22 Drug Upcoming Product-Specific Guidances for Generic Drug Product Development Regulatory Visit Page
Global 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 15-11-22 Drug FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use 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
Europe European Medicines Agency 10-11-22 Biologics Reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances 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
Switzerland 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
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 Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act 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 CMC 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
China National Medical Products Administration 27-10-22 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
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
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
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) CMC 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
Global 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
USA Food and Drug Administration 10-8-22 Medical Device Ethylene Oxide Risk from Commercial Sterilizers 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
Switzerland The Swiss Agency for Therapeutic Products 1-8-22 Drug Changes to Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4 Regulatory Visit Page
Europe European Medicines Agency 1-8-22 Drug Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures Regulatory Visit Page
USA Food and Drug Administration 1-8-22 Drug Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies (draft guidance) Publishing Visit Page
India Central Drugs Standard Control Organisation 29-7-22 Medical Device Price control on medical devices Regulatory Visit Page
Europe European Medicines Agency 28-7-22 Drug Key performance indicators (KPIs) to monitor the European clinical trials environment Clinical Visit Page
Europe European Medicines Agency 28-7-22 Drug Big Data Workplan 2022-2025 Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 27-7-22 Drug Outcome of the consultation on the proposed warning and advisory statements relating to the harm of opioid abuse Labeling Visit Page
Europe European Medicines Agency 27-7-22 Drug EMA response to the monkeypox public health emergency Regulatory Visit Page
USA Food and Drug Administration 25-7-22 Medical Device Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices Regulatory Visit Page
USA Food and Drug Administration 25-7-22 Drug Proposed Rule on Revising the National Drug Code Format Labeling Visit Page
USA Food and Drug Administration 22-7-22 Drug FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health Regulatory Visit Page
Europe European Medicines Agency 21-7-22 Drug ICH Guideline M12 on drug interaction studies (draft guidance) Clinical Visit Page
Australia Therapeutic Goods Administration 20-7-22 Drug Nitrosamine impurities in medicines - Information for sponsors and manufacturers Regulatory Visit Page
USA Food and Drug Administration 18-7-22 Medical Device Tracking Your Premarket Submission’s Progress (Progress Tracker) Regulatory Visit Page
Europe European Medicines Agency 15-7-22 Drug Towards better prevention of medicine shortages in the EU Regulatory Visit Page
Europe European Commission 14-7-22 Biologics Questions and answers on the proposal for a new legislation on blood, tissues, and cells Regulatory Visit Page
Europe European Commission 13-7-22 Medical Device MDCG 2022-12 - Harmonized administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR) Regulatory Visit Page
Australia Therapeutic Goods Administration 12-7-22 Drug Import, Advertising and Supply Compliance Priorities 2022-23 Regulatory Visit Page
Europe European Medicines Agency 12-7-22 Drug Information about the raw data proof-of-concept pilot for industry Clinical Visit Page
Europe European Medicines Agency 11-7-22 Drug Concept paper on the revision of the guideline on the chemistry of active substances Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 11-7-22 Drug Proposed warning and advisory statement for ocular decongestants used for eye redness and/or minor eye irritation: Do not use in children under 12 years of age Safety Visit Page
Europe European Medicines Agency 11-7-22 Vaccine ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines Regulatory Visit Page
India Central Drugs Standard Control Organisation 11-7-22 Medical Device Clarification on medical devices quality certificates Regulatory Visit Page
Europe European Medicines Agency 8-7-22 Drug Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimize risk of meningioma Pharmacovigilance Visit Page
Europe European Medicines Agency 8-7-22 Drug List of the “main therapeutic groups” (MTGs) in crisis preparedness Regulatory Visit Page
India Central Drugs Standard Control Organisation 7-7-22 Medical Device Guidance on Stability Studies of In-vitro Diagnostic Medical Device (draft guidance) Regulatory Visit Page
India Central Drugs Standard Control Organisation 7-7-22 Medical Device Guidance on post-market surveillance of In-Vitro Diagnostic Medical Device (draft guidance) Regulatory Visit Page
India Central Drugs Standard Control Organisation 7-7-22 Medical Device Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) (draft guidance) Regulatory Visit Page
Australia Therapeutic Goods Administration 4-7-22 Biologics Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response Regulatory Visit Page
Europe European Commission 4-7-22 Medical Device Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council Regulatory Visit Page
Malaysia National Pharmaceutical Regulatory Agency 1-7-22 Drug Active Pharmaceutical Ingredient (API) Information (PART II S) for product registration application via quest system Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Changes to Disposable Manufacturing Materials: Questions and Answers Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings Clinical Visit Page
USA Food and Drug Administration 1-7-22 Drug and Biological Product General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products Clinical Visit Page
USA Food and Drug Administration 1-7-22 Drug and Biological Product Real-Time Oncology Review (RTOR) (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Orange Book Questions and Answers Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Conducting Remote Regulatory Assessments Questions and Answers (draft guidance) Regulatory Visit Page
Europe European Commission 1-7-22 Medical Device First Spanish group designated under MDR Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” (draft guidance) Labeling Visit Page
USA Food and Drug Administration 1-7-22 Drug Evaluation of Therapeutic Equivalence (draft guidance) Regulatory Visit Page
The Philippines Philippines FDA 1-7-22 Medical Device Amendment to FDA Circular NO. 2017-013, entitled, “guidelines on the issuance of clearance for customs release (CFCR) of radiation devices Regulatory Visit Page
Malaysia National Pharmaceutical Regulatory Agency 1-7-22 Drug Malaysian variation guideline for pharmaceutical products Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format Labeling Visit Page
Europe European Medicines Agency 1-7-22 Drug Quality of medicines questions and answers: Part 2 Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug Identifying Trading Partners Under the Drug Supply Chain Security Act (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-7-22 Drug DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 30-6-22 Medical Device General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma Regulatory Visit Page
Europe European Medicines Agency 28-6-22 Drug Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability  Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 27-6-22 Medical Device Guide to Performance Studies Conducted in Ireland Clinical Visit Page
Malaysia Medical Device Authority 24-6-22 Medical Device Medical device guidance document licensing for establishment Regulatory Visit Page
USA Food and Drug Administration 21-6-22 Medical Device Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures Clinical Visit Page
Europe European Commission 20-6-22 Medical Device Tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices Regulatory Visit Page
Europe European Commission 20-6-22 Medical Device Fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices Regulatory Visit Page
Europe European Medicines Agency 17-6-22 Medical Device Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics Regulatory Visit Page
The Philippines Philippines FDA 16-6-22 Drug and Biological Product Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 “Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals Regulatory Visit Page
USA Food and Drug Administration 16-6-22 Biologics Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 16-6-22 Medical Device Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions Regulatory Visit Page
USA Food and Drug Administration 15-6-22 Drug Q9(R1) Quality Risk Management; International Council for Harmonization (draft guidance) Quality Visit Page
Europe European Medicines Agency 15-6-22 Vaccine Start of rolling review for adapted Comirnaty COVID-19 vaccine Regulatory Visit Page
India Central Drugs Standard Control Organisation 14-6-22 Drug Draft proposal to include bar codes or QR codes for identified medicinal products Labeling Visit Page
USA Food and Drug Administration 14-6-22 Drug Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (Draft Guidance) Clinical Visit Page
Europe European Commission 13-6-22 Medical Device MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements Regulatory Visit Page
The Philippines Philippines FDA 10-6-22 Drug Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes Regulatory Visit Page
Italy Italian Medicines Agency 7-6-22 Drug Launch of new Pharmacovigilance Network Pharmacovigilance Visit Page
USA Food and Drug Administration 6-6-22 Drug and Biological Product Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products Regulatory Visit Page
Europe European Commission 3-6-22 Medical Device EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation Clinical Visit Page
France French National Agency for the Safety of Medicines and Health Products 2-6-22 Drug New edition of good pharmacovigilance practices Pharmacovigilance Visit Page
Australia Therapeutic Goods Administration 1-6-22 Medical Device Uniform Recall Procedure for Therapeutic Goods (URPTG) Regulatory Visit Page
USA Food and Drug Administration 1-6-22 Drug and Biological Product Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment Clinical Visit Page
USA Food and Drug Administration 1-6-22 Drug and Biological Product Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment Clinical Visit Page
Japan Pharmaceuticals and Medical Devices Agency 1-6-22 Drug-Device Combination Pharmaceuticals and Medical Devices Safety Information Safety Visit Page
USA Food and Drug Administration 26-5-22 Medical Device Performance studies with IVD Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 26-5-22 Medical Device New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022 Clinical Visit Page
Japan Pharmaceuticals and Medical Devices Agency 18-3-22 Drug Questions and Answers (Qs and As) on Risk Management Plan Quality Visit Page
The Philippines Philippines FDA 13-1-21 Drug Revised guidelines on the cold chain Revised guidelines on the cold chain Revised guidelines on the cold chain and establishments Labeling Visit Page
Malaysia National Pharmaceutical Regulatory Agency 1-1-21 Medicine Drug Registration Guidance Document (DRGD) Registration Visit Page
Europe European Medicines Agency 1-1-21 Drug-Device Combination "Pilot phase for CHMP early contact with patient / consumer organisations" Clinical Visit Page
Europe European Medicines Agency 1-1-70 Drug Guideline on influenza vaccines – submission and procedural requirements Regulatory Visit Page

Country/Region

USA

Date of Publishing

28-6-23

Product Type

Medical Device

Topic

Patient-Matched Guides to Orthopedic Implants (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-6-23

Product Type

Medical Device

Topic

CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-6-23

Product Type

Drug

Topic

Assessment of Facility-Based Deficiency Major-to-Minor Reclassification Requests

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

23-6-23

Product Type

Drug

Topic

Migraine: Developing Drugs for Preventive Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

Global

Date of Publishing

20-6-23

Product Type

Drug

Topic

ICH press release

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

20-6-23

Product Type

Drug

Topic

Oncology Drug Products Used with Certain In Vitro Diagnostic Tests: Pilot Program

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

19-6-23

Product Type

Drug

Topic

Revised Policy document PA/PH/CEP (04) 1, 7R on Content of the CEP dossier released for public consultation

Domain

Regulatory

URL

Country/Region

Argentina

Date of Publishing

16-6-23

Product Type

Drug

Topic

Argentina, Brazil and Chile enter the dialogue for the integration of an international health agency

Domain

Regulatory

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

Switzerland

Date of Publishing

15-6-23

Product Type

Drug

Topic

https://www.swissmedic.ch/swissmedic/en/home/kpa/aktuell-kpa/anpassung-wl-homoeopathika-anthroposophika-weitere-kpa.html

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

15-6-23

Product Type

Drug

Topic

150-day assessment for national applications for medicines

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

14-6-23

Product Type

Medical Device

Topic

Content of Premarket Submissions for Device Software Functions

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

9-6-23

Product Type

Drug

Topic

Centrally Authorised Products (CAPs) Bridging Mechanism

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

6-6-23

Product Type

Drug

Topic

FDA Announces Additional Steps to Modernize Clinical Trials

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

5-6-23

Product Type

Drug

Topic

Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment

Domain

Non-Clinical

URL

Country/Region

USA

Date of Publishing

5-6-23

Product Type

Drug

Topic

Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals

Domain

Non-Clinical

URL

Country/Region

Australia

Date of Publishing

2-6-23

Product Type

Drug

Topic

TGA supports MHRA’s new international recognition framework for medicines

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-6-23

Product Type

Medical Device

Topic

Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program

Domain

Regulatory

URL

Country/Region

Singapore

Date of Publishing

1-6-23

Product Type

Medical Device

Topic

HSA's SRA status for in vitro diagnostic medical devices (IVD)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-6-23

Product Type

Drug

Topic

Digital therapeutics which could help transform patient care available only in a limited number of European countries

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-6-23

Product Type

Drug

Topic

Real-world evidence framework to support EU regulatory decision-making

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

1-6-23

Product Type

Drug

Topic

Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System (draft for comments)

Domain

Labeling

URL

Country/Region

The Philippines

Date of Publishing

1-6-23

Product Type

Drug and Biological Product

Topic

Public Consultation on the Proposed Guidelines on the Regulation of Stem Cell Facilities

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

1-6-23

Product Type

Drug

Topic

Updated Guidelines on the Application for License to Operate of Health Product Establishments with the Food and Drug Administration (Draft guidance for comments)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-6-23

Product Type

Medical Device

Topic

Transition to new manufacturer evidence for IVD medical devices Guidance for manufacturers and sponsors of IVD medical devices

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-6-23

Product Type

Medical Device

Topic

Consultation on the regulatory requirements for medical devices containing materials of animal, microbial or recombinant origin

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-6-23

Product Type

Drug

Topic

Oral anticoagulants can cause serious kidney damage in rare circumstances

Domain

Safety

URL

Country/Region

USA

Date of Publishing

1-6-23

Product Type

Drug

Topic

Presenting Quantitative Efficacy and Risk Information in Direct-to-Consumer (DTC) Promotional Labeling and Advertisements

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-6-23

Product Type

Drug

Topic

Psychedelic Drugs: Considerations for Clinical Investigations

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-6-23

Product Type

Drug

Topic

Formal Dispute Resolution and Administrative Hearings of Final Administrative Orders Under Section 505G of the Food, Drug, and Cosmetic Act

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-6-23

Product Type

Drug

Topic

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

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-6-23

Product Type

Drug

Topic

Drug-Drug Interaction Assessment for Therapeutic Proteins

Domain

Clinical

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

Europe

Date of Publishing

26-5-23

Product Type

Food & Food Supplement Regulation

Topic

Scientific opinion on the tolerable upper intake level for vitamin B6

Domain

Novel food

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

Global

Date of Publishing

19-5-23

Product Type

Drug

Topic

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

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

17-5-23

Product Type

Food & Food Supplement Regulation

Topic

Safety of yellow/orange tomato extract as a novel food pursuant to Regulation (EU) 2015/2283

Domain

Novel food

URL

Country/Region

Europe

Date of Publishing

17-5-23

Product Type

Food & Food Supplement Regulation

Topic

Scientific opinion on the tolerable upper intake level for vitamin B6

Domain

Dietary reference values

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

USA

Date of Publishing

10-5-23

Product Type

Food & Food Supplement Regulation

Topic

Cyflufenamid; Pesticide Tolerance, 40 CFR” and “Fomesafen; Pesticide Tolerances, 40 CFR”

Domain

Pesticides

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

New Zealand

Date of Publishing

8-5-23

Product Type

Drug

Topic

Review of pholcodine-containing medicines

Domain

Safety

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

Brazil

Date of Publishing

4-5-23

Product Type

Drug

Topic

Anvisa updates the rule governing requirements for clinical analysis exams

Domain

Clinical

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

India

Date of Publishing

2-5-23

Product Type

Medical Device

Topic

Streamlining of medical device regulations

Domain

Regulatory

URL

Country/Region

Singapore

Date of Publishing

2-5-23

Product Type

Medical Device

Topic

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

Domain

Regulatory

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

Global

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

Singapore

Date of Publishing

18-4-23

Product Type

Food & Food Supplement Regulation

Topic

Amends Food Regulations 2023 on Veterinary Drug Residues

Domain

Veterinary

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 Regulation

Topic

Publishes Tolerances for Deltamethrin on Various Agricultural Commodities

Domain

Pesticides

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

Global

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

Bahrain

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

Global

Date of Publishing

3-4-23

Product Type

Medical Device

Topic

Personalized Medical Devices – Production Verification and Validation

Domain

Regulatory

URL

Country/Region

Global

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

Global

Date of Publishing

3-4-23

Product Type

Medical Device

Topic

Software and Artificial Intelligence (AI) as a Medical Device

Domain

Regulatory

URL

Country/Region

Global

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

Global

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

Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Domain

Regulatory

URL

Country/Region

Japan

Date of Publishing

3-4-23

Product Type

Drug

Topic

Ministerial Ordinance on Good Clinical Practice for Drugs

Domain

Clinical

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

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

Drug

Topic

Clinical trial considerations to support accelerated approval of oncology therapeutics (draft guidance)

Domain

Clinical

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

USA

Date of Publishing

20-3-23

Product Type

Medical Device

Topic

Send and Track Medical Device Premarket Submissions Online: CDRH Portal

Domain

Regulatory

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 Regulation

Topic

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

Domain

Ingredient

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

Global

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

Europe

Date of Publishing

1-3-23

Product Type

Medical Device

Topic

Extension of the MDR transitional period and removal of the ‘sell off’ periods

Domain

Regulatory

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

Regulatory

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

New Zealand

Date of Publishing

27-2-23

Product Type

Drug

Topic

Outcome of the consultation on the proposed warning and advisory statements for ocular decongestants for eye redness and/or minor eye irritation

Domain

Safety

URL

Country/Region

Malaysia

Date of Publishing

24-2-23

Product Type

Medical Device

Topic

Malaysia MDA introduces new online payment system

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

23-2-23

Product Type

Medical Device

Topic

Examples of Medical Device Misconnections

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

USA

Date of Publishing

21-2-23

Product Type

Drug

Topic

Press Statement: 21 February 2023 FDA Philippines Launches Task Force Fleming to Make Safe and Effective Covid-19 Drugs More Accessible to All Filipinos

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

20-2-23

Product Type

Medical Device

Topic

Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

16-2-23

Product Type

Biologics

Topic

Adjuvants in vaccines for human use - Scientific guideline

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

10-2-23

Product Type

Drug

Topic

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 - 9 February 2023

Domain

Pharmacovigilance

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

USA

Date of Publishing

9-2-23

Product Type

Medical Device

Topic

Medical Device Material Safety Summaries

Domain

Safety

URL

Country/Region

Australia

Date of Publishing

8-2-23

Product Type

Drug

Topic

Avoid prescribing pregabalin in pregnancy if possible

Domain

Safety

URL

Country/Region

USA

Date of Publishing

8-2-23

Product Type

Drug

Topic

Artificial Intelligence/Machine Learning Assisted Image Analysis for Characterizing Biotherapeutics

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

7-2-23

Product Type

Drug

Topic

ANDA Assessment Program | GDUFA III Performance Goals and Program Enhancements

Domain

Regulatory

URL

Country/Region

Global

Date of Publishing

7-2-23

Product Type

Medical Device

Topic

IMDRF Terms of Reference

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

6-2-23

Product Type

Drug

Topic

Guidance for Stepwise PIP pilot

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

6-2-23

Product Type

Drug

Topic

EFPIA response to EU Commission proposal for revised EMA Fees regulation

Domain

Regulatory

URL

Country/Region

Global

Date of Publishing

3-2-23

Product Type

Medical Device

Topic

Medical Device Regulatory Review Report: Guidance Regarding Information to be Included

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-2-23

Product Type

Drug

Topic

Public consultation on a multi-stakeholder platform to improve clinical trials in the EU

Domain

Clinical

URL

Country/Region

UK

Date of Publishing

3-2-23

Product Type

Medical Device

Topic

Medical technology strategy

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

3-2-23

Product Type

Drug

Topic

Change to classification of psilocybin and MDMA to enable prescribing by authorized psychiatrists.

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

3-2-23

Product Type

Drug

Topic

TGA makes interim decision to reduce maximum paracetamol pack sizes.

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-2-23

Product Type

Drug

Topic

ICH guideline Q9 (R1) on quality risk management

Domain

Quality

URL

Country/Region

USA

Date of Publishing

3-2-23

Product Type

Medical Device

Topic

Total Product Life Cycle Advisory Program (TAP)

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

Europe

Date of Publishing

1-2-23

Product Type

Medical Device

Topic

Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-2-23

Product Type

Medical Device

Topic

Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-2-23

Product Type

Drug

Topic

Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-2-23

Product Type

Drug

Topic

Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

The Philippines

Date of Publishing

1-2-23

Product Type

Drug

Topic

Guidelines on Food and Drug Administration’s Regulatory Responses During Declared National or State of Public Health Emergencies (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-2-23

Product Type

Drug

Topic

Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-2-23

Product Type

Drug

Topic

Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-2-23

Product Type

Drug

Topic

Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

31-1-23

Product Type

Drug

Topic

Use of Clinical Trials Information System becomes mandatory for new clinical trial applications in the EU

Domain

Clinical

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

Ireland

Date of Publishing

30-1-23

Product Type

Drug

Topic

Fees for Human Products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-1-23

Product Type

Medical Device

Topic

Health Canada and FDA eSTAR Pilot

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

26-1-23

Product Type

Drug

Topic

ICH Guideline M13A on bioequivalence for immediate release solid oral dosage forms

Domain

Clinical

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

Europe

Date of Publishing

25-1-23

Product Type

Medical Device

Topic

Scientific advice pilot for high-risk medical devices device

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

24-1-23

Product Type

Drug

Topic

Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research; Guidance for Industry; Availability

Domain

Clinical

URL

Country/Region

UK

Date of Publishing

24-1-23

Product Type

Drug

Topic

European Commission Decision Reliance Procedure (ECDRP) extension

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

23-1-23

Product Type

Drug

Topic

Pharmacovigilance Risk Assessment Committee (PRAC): Work Plan 2023

Domain

Pharmacovigilance

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

Europe

Date of Publishing

20-1-23

Product Type

Drug

Topic

Joint statement by Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) on shortages of antibiotic medicines

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

Europe

Date of Publishing

19-1-23

Product Type

Drug

Topic

Mandatory use of CTIS from 31 January 2023 for all new clinical trial applications

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

17-1-23

Product Type

Medical Device

Topic

Classification of the Prognostic Test for Assessment of Liver Related Disease Progression

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

13-1-23

Product Type

Medical Device

Topic

Classification of the Digital Therapy Device To Reduce Sleep Disturbance for Psychiatric Conditions

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

USA

Date of Publishing

12-1-23

Product Type

Medical Device

Topic

Photobiomodulation (PBM) Devices - 2 Premarket Notification [510(k)] 3 Submissions (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

12-1-23

Product Type

Medical Device

Topic

Agreement on Mutual Recognition between the Swiss Confederation and the United States of America Relating to Pharmaceutical Good Manufacturing Practice

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

11-1-23

Product Type

Drug

Topic

Position paper by Swissmedic and swissethics on decentralized clinical trials (DCTs) with medicinal products

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

6-1-23

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

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

USA

Date of Publishing

5-1-23

Product Type

Medical Device

Topic

Orthopedic Devices; Classification of the Bone Indentation Device

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

5-1-23

Product Type

Medical Device

Topic

Orthopedic Devices; Classification of the Implantable Post-Surgical Kinematic Measurement Knee Device

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

5-1-23

Product Type

Medical Device

Topic

Neurological Devices; Classification of the Brain Stimulation Programming Planning Software

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

3-1-23

Product Type

Drug-Device Combination

Topic

Guideline on the Regulation of Therapeutic Products in New Zealand

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

3-1-23

Product Type

Drug

Topic

Updated Guidelines for Availing Compassionate Special Permit for the Restricted Use of Unregistered or Unauthorized Drug Products including Vaccines and Medical Devices (draft for comments)

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

3-1-23

Product Type

Medical Device

Topic

Guidelines on the Conduct of Regulatory Inspections for Radiation Facilities

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

Switzerland

Date of Publishing

3-1-23

Product Type

Medical Device

Topic

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

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

3-1-23

Product Type

Drug-Device Combination

Topic

Guideline for drug-medical device and medical device-drug combination products - endorsement letter application - adverse drug reaction and incident reporting

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

3-1-23

Product Type

Medical Device

Topic

Gastroenterology-Urology Devices; Classification of the Gastrointestinal Lesion Software Detection System

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

How to submit an application for registration of a refurbished medical device

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-1-23

Product Type

Drug

Topic

Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products — Content and Format (draft guidance)

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

1-1-23

Product Type

Drug

Topic

Guidance on good manufacturing practice and good distribution practice: Questions and answers

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-1-23

Product Type

Medical Device

Topic

Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Domain

Regulatory

URL

Country/Region

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

1-1-23

Product Type

Format and Content of a REMS Document

Topic

Format and Content of a REMS Document

Domain

Safety

URL

Country/Region

USA

Date of Publishing

30-12-22

Product Type

Medical Device

Topic

Neurological Devices; Classification of the Pediatric Autism Spectrum Disorder Diagnosis Aid

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-12-22

Product Type

Medical Device

Topic

Classification of the Interventional Cardiovascular Implant Simulation Software Device

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-12-22

Product Type

Medical Device

Topic

Classification of the Adjunctive Hemodynamic Indicator with Decision Point

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

International

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

Global

Date of Publishing

19-12-22

Product Type

Medical Device

Topic

IMDRF Standard Operating Procedures

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

UK

Date of Publishing

5-12-22

Product Type

Medical Device

Topic

Guidance for manufacturers on vigilance

Domain

Pharmacovigilance

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

Medical Device

Topic

Requirements for labelling of medical devices

Domain

Labeling

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

Global

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

15-11-22

Product Type

Drug

Topic

FDA Announces Preliminary Assessment that Certain Naloxone Products Have the Potential to be Safe and Effective for Over-the-Counter Use

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

Europe

Date of Publishing

10-11-22

Product Type

Biologics

Topic

Reflection paper on criteria to be considered for the evaluation of new active substance (NAS) status of biological substances

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

Switzerland

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

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

Compounding Certain Beta-Lactam Products in Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic Act

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

Domain

CMC

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

China

Date of Publishing

27-10-22

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

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

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

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

CMC

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

Global

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

USA

Date of Publishing

10-8-22

Product Type

Medical Device

Topic

Ethylene Oxide Risk from Commercial Sterilizers

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

Switzerland

Date of Publishing

1-8-22

Product Type

Drug

Topic

Changes to Guidance document Authorisation procedures for COVID-19 medicinal products during a pandemic HMV4

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-8-22

Product Type

Drug

Topic

Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-8-22

Product Type

Drug

Topic

Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies (draft guidance)

Domain

Publishing

URL

Country/Region

India

Date of Publishing

29-7-22

Product Type

Medical Device

Topic

Price control on medical devices

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

28-7-22

Product Type

Drug

Topic

Key performance indicators (KPIs) to monitor the European clinical trials environment

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

28-7-22

Product Type

Drug

Topic

Big Data Workplan 2022-2025

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

27-7-22

Product Type

Drug

Topic

Outcome of the consultation on the proposed warning and advisory statements relating to the harm of opioid abuse

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

27-7-22

Product Type

Drug

Topic

EMA response to the monkeypox public health emergency

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

25-7-22

Product Type

Medical Device

Topic

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

25-7-22

Product Type

Drug

Topic

Proposed Rule on Revising the National Drug Code Format

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

22-7-22

Product Type

Drug

Topic

FDA Details Optimized Approach for Regulatory Oversight Tools to Better Protect Public Health

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

21-7-22

Product Type

Drug

Topic

ICH Guideline M12 on drug interaction studies (draft guidance)

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

20-7-22

Product Type

Drug

Topic

Nitrosamine impurities in medicines - Information for sponsors and manufacturers

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

18-7-22

Product Type

Medical Device

Topic

Tracking Your Premarket Submission’s Progress (Progress Tracker)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

15-7-22

Product Type

Drug

Topic

Towards better prevention of medicine shortages in the EU

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

14-7-22

Product Type

Biologics

Topic

Questions and answers on the proposal for a new legislation on blood, tissues, and cells

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

13-7-22

Product Type

Medical Device

Topic

MDCG 2022-12 - Harmonized administrative practices and alternative technical solutions until Eudamed is fully functional (for IVDR)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

12-7-22

Product Type

Drug

Topic

Import, Advertising and Supply Compliance Priorities 2022-23

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

12-7-22

Product Type

Drug

Topic

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

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

11-7-22

Product Type

Drug

Topic

Concept paper on the revision of the guideline on the chemistry of active substances

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

11-7-22

Product Type

Drug

Topic

Proposed warning and advisory statement for ocular decongestants used for eye redness and/or minor eye irritation: Do not use in children under 12 years of age

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

11-7-22

Product Type

Vaccine

Topic

ECDC and EMA update recommendations on additional booster doses of mRNA COVID-19 vaccines

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

11-7-22

Product Type

Medical Device

Topic

Clarification on medical devices quality certificates

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

8-7-22

Product Type

Drug

Topic

Medicines containing nomegestrol or chlormadinone: PRAC recommends new measures to minimize risk of meningioma

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

8-7-22

Product Type

Drug

Topic

List of the “main therapeutic groups” (MTGs) in crisis preparedness

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

7-7-22

Product Type

Medical Device

Topic

Guidance on Stability Studies of In-vitro Diagnostic Medical Device (draft guidance)

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

7-7-22

Product Type

Medical Device

Topic

Guidance on post-market surveillance of In-Vitro Diagnostic Medical Device (draft guidance)

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

7-7-22

Product Type

Medical Device

Topic

Overview on Performance Evaluation / External Evaluation of In vitro Diagnostic Medical Device (IVDMD) (draft guidance)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

4-7-22

Product Type

Biologics

Topic

Report on 'Cell, Gene and Tissue Regulatory Framework in Australia: Stakeholder Perspectives' - TGA response

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

4-7-22

Product Type

Medical Device

Topic

Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-7-22

Product Type

Drug

Topic

Active Pharmaceutical Ingredient (API) Information (PART II S) for product registration application via quest system

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Changes to Disposable Manufacturing Materials: Questions and Answers

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug and Biological Product

Topic

General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug and Biological Product

Topic

Real-Time Oncology Review (RTOR) (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Orange Book Questions and Answers

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Conducting Remote Regulatory Assessments Questions and Answers (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-7-22

Product Type

Medical Device

Topic

First Spanish group designated under MDR

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — “Dose Banding” (draft guidance)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Evaluation of Therapeutic Equivalence (draft guidance)

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

1-7-22

Product Type

Medical Device

Topic

Amendment to FDA Circular NO. 2017-013, entitled, “guidelines on the issuance of clearance for customs release (CFCR) of radiation devices

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-7-22

Product Type

Drug

Topic

Malaysian variation guideline for pharmaceutical products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

1-7-22

Product Type

Drug

Topic

Quality of medicines questions and answers: Part 2

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

Identifying Trading Partners Under the Drug Supply Chain Security Act (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-7-22

Product Type

Drug

Topic

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

30-6-22

Product Type

Medical Device

Topic

General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

28-6-22

Product Type

Drug

Topic

Call for companies to register their Industry Single Point of Contact (i-SPOC) on supply and availability 

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

27-6-22

Product Type

Medical Device

Topic

Guide to Performance Studies Conducted in Ireland

Domain

Clinical

URL

Country/Region

Malaysia

Date of Publishing

24-6-22

Product Type

Medical Device

Topic

Medical device guidance document licensing for establishment

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

21-6-22

Product Type

Medical Device

Topic

Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

20-6-22

Product Type

Medical Device

Topic

Tasks of and criteria for European Union reference laboratories in the field of in vitro diagnostic medical devices

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

20-6-22

Product Type

Medical Device

Topic

Fees that may be levied by EU reference laboratories in the field of in vitro diagnostic medical devices

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

17-6-22

Product Type

Medical Device

Topic

Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

16-6-22

Product Type

Drug and Biological Product

Topic

Implementing Guidelines on the Abridged and Verification Review Pathways for New Drug Registration Applications in accordance with Administrative Order No. 2020-0045 “Establishing Facilitated Registration Pathways for Drug Products including Vaccines and Biologicals

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

16-6-22

Product Type

Biologics

Topic

Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

16-6-22

Product Type

Medical Device

Topic

Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

15-6-22

Product Type

Drug

Topic

Q9(R1) Quality Risk Management; International Council for Harmonization (draft guidance)

Domain

Quality

URL

Country/Region

Europe

Date of Publishing

15-6-22

Product Type

Vaccine

Topic

Start of rolling review for adapted Comirnaty COVID-19 vaccine

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

14-6-22

Product Type

Drug

Topic

Draft proposal to include bar codes or QR codes for identified medicinal products

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

14-6-22

Product Type

Drug

Topic

Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials (Draft Guidance)

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

13-6-22

Product Type

Medical Device

Topic

MDCG 2022-11 - MDCG Position Paper: Notice to manufacturers to ensure timely compliance with MDR requirements

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

10-6-22

Product Type

Drug

Topic

Banning of all Mercury-Added Thermometers, Sphygmomanometers, Dental Amalgam Capsules and Liquid Mercury for Use in Dental Restorative Purposes

Domain

Regulatory

URL

Country/Region

Italy

Date of Publishing

7-6-22

Product Type

Drug

Topic

Launch of new Pharmacovigilance Network

Domain

Pharmacovigilance

URL

Country/Region

USA

Date of Publishing

6-6-22

Product Type

Drug and Biological Product

Topic

Assessment of the Appropriate Net Container Content for Injectable Drug and Biological Products

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-6-22

Product Type

Medical Device

Topic

EFPIA statement on the concerning impact of the In Vitro Diagnostic Regulation

Domain

Clinical

URL

Country/Region

France

Date of Publishing

2-6-22

Product Type

Drug

Topic

New edition of good pharmacovigilance practices

Domain

Pharmacovigilance

URL

Country/Region

Australia

Date of Publishing

1-6-22

Product Type

Medical Device

Topic

Uniform Recall Procedure for Therapeutic Goods (URPTG)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-6-22

Product Type

Drug and Biological Product

Topic

Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-6-22

Product Type

Drug and Biological Product

Topic

Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment

Domain

Clinical

URL

Country/Region

Japan

Date of Publishing

1-6-22

Product Type

Drug-Device Combination

Topic

Pharmaceuticals and Medical Devices Safety Information

Domain

Safety

URL

Country/Region

USA

Date of Publishing

26-5-22

Product Type

Medical Device

Topic

Performance studies with IVD

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

26-5-22

Product Type

Medical Device

Topic

New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022

Domain

Clinical

URL

Country/Region

Japan

Date of Publishing

18-3-22

Product Type

Drug

Topic

Questions and Answers (Qs and As) on Risk Management Plan

Domain

Quality

URL

Country/Region

The Philippines

Date of Publishing

13-1-21

Product Type

Drug

Topic

Revised guidelines on the cold chain Revised guidelines on the cold chain Revised guidelines on the cold chain and establishments

Domain

Labeling

URL

Country/Region

Malaysia

Date of Publishing

1-1-21

Product Type

Medicine

Topic

Drug Registration Guidance Document (DRGD)

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

1-1-21

Product Type

Drug-Device Combination

Topic

"Pilot phase for CHMP early contact with patient / consumer organisations"

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

1-1-70

Product Type

Drug

Topic

Guideline on influenza vaccines – submission and procedural requirements

Domain

Regulatory

URL

;