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Regulatory Intelligence

Navigate the Regulatory Landscape and Make Smart Decisions

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


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Country/Region Health Authority Date of Publishing Product Type Topic Domain URL
USA Food and Drug Administration 17-11-22 Drug Upcoming Product-Specific Guidances for Generic Drug Product Development Regulatory Visit Page
Australia Therapeutic Goods Administration 15-11-22 Medical Device Post-market review of ventilators, CPAP and BiPAP devices Pharmacovigilance Visit Page
UK 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
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Drug Administration 27-10-22 Drug Measuring Growth and Evaluating Pubertal Development in Pediatric Clinical Trials (draft guidance) Clinical Visit Page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and Drug Administration 25-10-22 Drug In Vitro Permeation Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance) Regulatory Visit Page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Food and Drug Administration 21-10-22 Drug In Vitro Release Test Studies for Topical Drug Products Submitted in ANDAs (draft guidance) Regulatory Visit Page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21-10-22 Drug Physicochemical and Structural (Q3) Characterization of Topical Drug Products Submitted in ANDAs (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 21-10-22 Drug Topical Dermatologic Corticosteroids: In Vivo Bioequivalence (draft guidance) Regulatory Visit Page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 18-10-22 Drug ANDA Submissions – Prior Approval Supplements Under GDUFA Regulatory 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
Australia Therapeutic Goods Administration 17-10-22 Drug Pharmacovigilance Inspection Program Risk Assessment Survey Pharmacovigilance Visit Page
USA Food and Drug Administration 17-10-22 Drug Tissue Agnostic Drug Development in Oncology Clinical Visit Page
USA Food and Drug Administration 17-10-22 Drug Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials Clinical Visit Page
USA Food and Drug Administration 17-10-22 Drug Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment Clinical 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
USA Food and Drug Administration 14-10-22 Drug Comparability Protocols for Post approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA CMC Visit Page
USA Food and Drug Administration 12-10-22 Drug Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act Regulatory Visit Page
India Central Drugs Standard Control Organisation 11-10-22 Medical Device Classification of medical device pertaining to oncology under the provisions of medical devices rules, 2017 Regulatory Visit Page
Denmark Danish Medicines Agency 11-10-22 Drug Current Danish QRD template to be used in connection with the granting of marketing authorizations Regulatory Visit Page
Australia Therapeutic Goods Administration 7-10-22 Drug GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic Regulatory Visit Page
Australia Therapeutic Goods Administration 7-10-22 Drug Boundary and combination products guidance - medicines, medical devices, and biologicals Regulatory Visit Page
USA Food and Drug Administration 7-10-22 Medical Device Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order Clinical Visit Page
USA Food and Drug Administration 6-10-22 Medical Device Post market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act 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 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
The Philippines Philippines FDA 3-10-22 Drug Amendment to Administrative Order No. 2020-0017 entitled, “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003” (Draft guidance) Regulatory Visit Page
India Central Drugs Standard Control Organisation 3-10-22 Drug National list of Essential Medicines 2022 Regulatory Visit Page
Japan Pharmaceuticals and Medical Devices Agency 3-10-22 Drug PDG Welcomes Indian Pharmacopoeia Commission to Pilot for Global Expansion Regulatory Visit Page
Ireland Health Products Regulatory Authority 1-10-22 Drug Public Consultation on Annual Review and Proposal for Fees – Financial Year 2023 Regulatory Visit Page
Europe European Medicines Agency 30-9-22 Drug Data Quality Framework for EU medicines regulation Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 30-9-22 Drug European Commission Decision Reliance Procedure (EC DRP) extension Regulatory Visit Page
India Central Drugs Standard Control Organisation 30-9-22 Medical Device Regulation of all Class A & B Medical Devices under Licensing regime Regulatory Visit Page
Global INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE 29-9-22 Drug Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A(R2) Safety Visit Page
UK Medicines and Healthcare products Regulatory Agency 29-9-22 Medical Device MHRA appoints first new UK Approved Body to certify medical devices since Brexit Regulatory Visit Page
Europe European Medicines Agency 29-9-22 Drug EMA pilot offers enhanced support to academic and non-profit developers of advanced therapy medicinal products Regulatory Visit Page
Australia Therapeutic Goods Administration 28-9-22 Drug User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version Safety Visit Page
USA Food and Drug Administration 28-9-22 Medical Device Display Devices for Diagnostic Radiology Regulatory Visit Page
USA Food and Drug Administration 28-9-22 Medical Device Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions Regulatory Visit Page
USA Food and Drug Administration 28-9-22 Medical Device Clinical Decision Support Software Regulatory Visit Page
USA Food and Drug Administration 28-9-22 Medical Device Policy for Device Software Functions and Mobile Medical Applications Regulatory Visit Page
USA Food and Drug Administration 28-9-22 Drug Protection of Human Subjects and Institutional Review Boards Regulatory Visit Page
USA Food and Drug Administration 28-9-22 Vaccine Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised); Immediately in Effect Guidance for Commercial Manufacturers and Food and Drug Administration Staff; Availability 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
Global INTERNATIONAL COUNCIL FOR HARMONISATION OF TECHNICAL REQUIREMENTS FOR PHARMACEUTICALS FOR HUMAN USE 27-9-22 Drug A selective approach to safety data collection in specific late-stage pre-approval or post-approval clinical trials E19 Safety 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
USA Food and Drug Administration 23-9-22 Drug New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials Clinical Visit Page
USA Food and Drug Administration 22-9-22 Medical Device Electronic Submission Template for Medical Device 510(k) Submissions Regulatory Visit Page
Europe European Medicines Agency 19-9-22 Biologics Biosimilar medicines can be interchanged Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 14-9-22 Drug Potential nitrosamine contamination – harmonised implementation (update) Regulatory Visit Page
Australia Therapeutic Goods Administration 14-9-22 Drug Independent review of paracetamol overdose Safety Visit Page
Europe European Commission 14-9-22 Medical Device MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR Regulatory Visit Page
Europe European Commission 14-9-22 Medical Device MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies Regulatory Visit Page
USA Food and Drug Administration 14-9-22 Drug Annual Summary Reporting Requirements Under the Right to Try Act Regulatory Visit Page
USA Food and Drug Administration 14-9-22 Medical Device SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests Regulatory Visit Page
Japan Pharmaceuticals and Medical Devices Agency 13-9-22 Drug Labeling of Codes on Containers to Identify Regenerative Medical Products, etc Labeling Visit Page
Japan Pharmaceuticals and Medical Devices Agency 13-9-22 Drug Labeling of Codes on Containers to Identify Prescription Drugs Labeling Visit Page
USA Food and Drug Administration 13-9-22 Drug Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List Under the 21st Century Cures Act Regulatory Visit Page
USA Food and Drug Administration 13-9-22 Medical Device Computer Software Assurance for Production and Quality System Software (draft guidance) Regulatory Visit Page
India Central Drugs Standard Control Organisation 9-9-22 Medical Device Classification of non-sterile, non-powered, hand-held, or hand-manipulated surgical instruments for general use intended to be used in surgical procedures Regulatory Visit Page
Europe European Commission 8-9-22 Medical Device Medical devices - reclassification of products without an intended medical purpose Regulatory Visit Page
Europe European Commission 7-9-22 Medical Device Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices Regulatory Visit Page
USA Food and Drug Administration 7-9-22 Drug Policy for Monkeypox Tests to Address the Public Health Emergency, Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff Regulatory Visit Page
Europe European Medicines Agency 2-9-22 Drug Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022 Pharmacovigilance Visit Page
Europe European Medicines Agency 1-9-22 Drug Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources Regulatory Visit Page
USA Food and Drug Administration 1-9-22 Drug Providing Over-the-Counter Monograph Submissions in Electronic Format (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 1-9-22 Drug Ethical Considerations for Clinical Investigations of Medical Products Involving Children Clinical Visit Page
Malaysia Medical Device Authority 1-9-22 Medical Device Guideline for re-registration of registered medical device Regulatory Visit Page
USA Food and Drug Administration 1-9-22 Drug Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products Regulatory Visit Page
USA Food and Drug Administration 1-9-22 Drug Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over the Counter and Prescription Drug Products Labeling Visit Page
USA Food and Drug Administration 1-9-22 Drug Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products (draft guidance) Labeling Visit Page
USA Food and Drug Administration 1-9-22 Drug General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products Guidance for Industry Pharmacovigilance Visit Page
UK Medicines and Healthcare products Regulatory Agency 1-9-22 Drug Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices Regulatory Visit Page
Australia Therapeutic Goods Administration 1-9-22 Drug Consultation: Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings, November 2022 Safety Visit Page
UK Medicines and Healthcare products Regulatory Agency 31-8-22 Drug Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees Regulatory Visit Page
Malaysia Medical Device Authority 30-8-22 Medical Device Licensing for establishment Regulatory Visit Page
Europe European Commission 26-8-22 Medical Device MDCG 2022-14 - Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs Regulatory Visit Page
Europe European Commission 25-8-22 Medical Device evision - Manufacture of Sterile Medicinal Products Regulatory Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 23-8-22 Drug Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products Regulatory Visit Page
The Philippines Philippines FDA 23-8-22 Drug Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft for comments) Clinical Visit Page
Australia Therapeutic Goods Administration 17-8-22 Medical Device Exemption for Certain Clinical Decision Support Software Clinical Visit Page
USA Food and Drug Administration 17-8-22 Medical Device Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices Regulatory Visit Page
USA Food and Drug Administration 17-8-22 Medical Device Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions (draft guidance) Labeling Visit Page
USA Food and Drug Administration 17-8-22 Medical Device Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products Regulatory Visit Page
Australia Therapeutic Goods Administration 17-8-22 Medical Device Regulation of software based medical devices Regulatory Visit Page
Singapore Health Sciences Authority 12-8-22 Medical Device Potential increase of mortality and amputation risk associated with paclitaxel-coated devices Safety 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
International The International Council for Harmonisation 4-8-22 Drug Testing for carcinogenicity of pharmaceuticals Safety 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
USA Food and Drug Administration 3-8-22 Medical Device Sterilization for Medical Devices Regulatory Visit Page
Australia Therapeutic Goods Administration 1-8-22 Drug Regulatory options to potentially allow references to the TGA in therapeutic goods advertising Labeling Visit Page
Malaysia Medical Device Authority 1-8-22 Medical Device Harmonized classification of medical devices in ASEAN Regulatory Visit Page
USA Food and Drug Administration 1-8-22 Drug Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry (draft guidance) 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 UK to strengthen regulation of medical devices to protect patients Regulatory Visit Page
USA Food and Drug Administration 27-6-22 Drug Nonprescription Drug Product with an Additional Condition for Nonprescription Use Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 27-6-22 Drug Outcome of the consultation on the proposed warning and advisory statements relating to harm of long-term use and overuse of stimulant laxatives Labeling Visit Page
Australia Therapeutic Goods Administration 27-6-22 Medical Device Clinical evidence guidelines for medical devices Clinical Visit Page
USA Food and Drug Administration 24-6-22 Drug Considerations for the Development of Oligonucleotide Therapeutics (draft guidance) Clinical Visit Page
Malaysia Medical Device Authority 24-6-22 Medical Device Medical device guidance document licensing for establishment Regulatory Visit Page
The Philippines Philippines FDA 23-6-22 Drug Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP) Labeling Visit Page
USA Food and Drug Administration 23-6-22 Drug Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 23-6-22 Drug Assessing the Effects of Food on Drugs in Investigational New Drugs and New Drug Applications—Clinical Pharmacology Considerations Clinical Visit Page
USA Food and Drug Administration 23-6-22 Drug and Biological Product Considerations for Rescinding Breakthrough Therapy Designation 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
Ireland Health Products Regulatory Authority 15-6-22 Medical Device Guide to Performance Studies Conducted in Ireland Clinical 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
Malaysia Medical Device Authority 8-6-22 Medical Device Guideline for re-registration of registered medical device Regulatory Visit Page
Italy Italian Medicines Agency 7-6-22 Drug Launch of new Pharmacovigilance Network Pharmacovigilance Visit Page
USA Food and Drug Administration 7-6-22 Medical Device Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices--Questions and Answers (Revised); Withdrawal of Guidance Regulatory 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
USA Food and Drug Administration 6-6-22 Medical Device Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation 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
Europe European Commission 2-6-22 Drug Questions and answers - Complex clinical trials Clinical 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
The Philippines Philippines FDA 1-6-22 Drug Implementing Guidelines on the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines Regulatory Visit Page
USA Food and Drug Administration 1-6-22 Medical Device Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals Regulatory Visit Page
Europe European Commission 1-6-22 Medical Device Draft standardization request amending Implementing Decision C (2021) 2406 of 14.4.2021 Regulatory Visit Page
Switzerland The Swiss Agency for Therapeutic Products 1-6-22 Drug Applications for clinical trials for medicinal products Clinical Visit Page
Ireland Health Products Regulatory Authority 30-5-22 Drug Stakeholder Consultation on Registration of Processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the CTR Clinical Visit Page
Australia Therapeutic Goods Administration 27-5-22 Medical Device Seasonal Influenza Rapid Antigen Self-tests and Combination tests Clinical performance requirements and risk mitigation strategies Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 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 25-5-22 Medical Device Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products Regulatory Visit Page
USA Food and Drug Administration 20-5-22 Drug Product-Specific Guidance’s; Draft and Revised Draft Guidance’s for Industry; Availability Regulatory Visit Page
Europe European Medicines Agency 19-5-22 Drug Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address pediatric-specific clinical data requirements Clinical Visit Page
Europe European Medicines Agency 19-5-22 Drug Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections Clinical Visit Page
India Central Drugs Standard Control Organisation 18-5-22 Medical Device Suspension and cancellation of medical device licenses Regulatory Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 18-5-22 Drug Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies Regulatory Visit Page
International Pharmaceutical Inspection Convention (PIC) and the Pharmaceutical Inspection Co-operation Scheme (PIC Scheme) 16-5-22 Drug PIC/S work plan for 2022 Regulatory Visit Page
Europe European Commission 11-5-22 Medical Device Amending Implementing Decision (EU) 2021/1182 as regards harmonized standards for quality management systems, sterilization, and application of risk management to medical devices Quality Visit Page
Europe European Medicines Agency 11-5-22 Drug Public Consultation Concerning the Physical Attendance and The Location of Personal Residency of The Qualified Person Pharmacovigilance Visit Page
Europe European Medicines Agency 10-5-22 Drug Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes Clinical Visit Page
Australia Therapeutic Goods Administration 9-5-22 Drug Independent expert report on the risks of intentional self-poisoning with paracetamol Regulatory Visit Page
USA Food and Drug Administration 6-5-22 Medical Device Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (draft guidance) Regulatory Visit Page
Europe European Medicines Agency 5-5-22 Drug Good Clinical Practice (GCP) inspection procedures – annexures updated Clinical Visit Page
Australia Therapeutic Goods Administration 4-5-22 Drug Update to Manufacturing Principles for medicines, APIs & sunscreens Regulatory Visit Page
Europe European Commission 4-5-22 Medical Device MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR Regulatory Visit Page
USA Food and Drug Administration 4-5-22 Drug FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease Regulatory Visit Page
Denmark Danish Medicines Agency 3-5-22 Drug New executive order raises fees in the area of the Danish Medicines Agency Regulatory Visit Page
The Philippines Philippines FDA 2-5-22 Drug Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017 Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Drug Importation of Prescription Drugs Final Rule Questions and Answers Regulatory Visit Page
The Philippines Philippines FDA 2-5-22 Drug Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft guidance) Clinical Visit Page
USA Food and Drug Administration 2-5-22 Biologics Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Biologics Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Biologics Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components Regulatory Visit Page
Europe European Commission 2-5-22 Medical Device MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746 Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Drug Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors Safety Visit Page
USA Food and Drug Administration 2-5-22 Drug Risk Management Plans to Mitigate the Potential for Drug Shortages (draft guidance) Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Drug Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production Regulatory Visit Page
The Philippines Philippines FDA 2-5-22 Medical Device Good Storage and Distribution Practices for Medical Devices (draft guidance) Regulatory Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 2-5-22 Drug Review of Fees payable under the Medicines Act 1981 Regulatory Visit Page
USA Food and Drug Administration 2-5-22 Drug Benefit-Risk Considerations for Product Quality Assessments (draft guidance) CMC Visit Page
USA Food and Drug Administration 2-5-22 Drug Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Guidance for Industry (draft guidance) Clinical Visit Page
Switzerland The Swiss Agency for Therapeutic Products 2-5-22 Drug Questions and answers on the packaging and labelling requirements for medicinal products intended to prevent or combat COVID-19 Labeling Visit Page
Australia Therapeutic Goods Administration 29-4-22 Drug Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings Regulatory Visit Page
USA Food and Drug Administration 29-4-22 Drug Crohn’s Disease: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
USA Food and Drug Administration 29-4-22 Drug Ulcerative Colitis: Developing Drugs for Treatment (draft guidance) Clinical Visit Page
India Central Drugs Standard Control Organisation 28-4-22 Drug Procedure for regularization of FDCs Regulatory Visit Page
Malaysia Medical Device Authority 1-4-22 Medical Device Guidance on the rules of classification for general medical devices Regulatory Visit Page
International The International Council for Harmonisation 31-3-22 Drug Considerations with respect to future MIDD related guidelines - output from ich model-informed drug development (MIDD) Regulatory 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 3-2-22 Vaccine Amendment to FDA Circular No. 2020-029 entitled “Guidance on Applications for the Conduct of COVID-19 Clinical Trials Clinical Visit Page
New Zealand New Zealand Medicines and Medical Devices Safety 15-4-21 Drug Outcome of the consultation on the proposed changes to paracetamol warning and advisory statements Labeling Visit Page
Switzerland The Swiss Agency for Therapeutic Products 1-4-21 Medical Device New requirements and changes to authorisation practice as of May 2021 Registration Visit Page
USA Food and Drug Administration 25-3-21 Drug Upcoming Product-Specific Guidances for Complex Generic Drug Product Development Registration Visit Page
Europe European Commission 24-3-21 Vaccine New procedure to facilitate and speed up approval of adapted vaccines against Covid-19 variants Registration Visit Page
UK Medicines and Healthcare products Regulatory Agency 23-3-21 Drug-Device Combination MHRA pilots patient involvement in new applications Registration Visit Page
The Philippines Philippines FDA 23-3-21 Vaccine Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection Registration Visit Page
UK Medicines and Healthcare products Regulatory Agency 19-3-21 Drug-Device Combination Guidance for industry on MHRA's expectations for return to UK on-site inspections General Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 17-3-21 Drug Rapid implementation of the revised sartan monographs on 1 April 2021 Registration Visit Page
USA Food and Drug Administration 17-3-21 FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premark Review Process Registration Visit Page
Europe European Medicines Agency 17-3-21 Drug SWP response to CMDh questions on chlorobutanol General Visit Page
USA Food and Drug Administration 16-3-21 Medical Device Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions Regulatory Visit Page
Europe European Medicines Agency 15-3-21 Vaccine EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update Safety Visit Page
India National Pharmaceutical Pricing Authority 12-3-21 Medical Device Change in medical device pricing General Visit Page
Europe European Medicines Agency 12-3-21 Vaccine Labelling flexibilities for COVID-19 therapeutics Labeling Visit Page
Canada Health Canada 12-3-21 Drug "Electronic media in prescription drug labelling" Labeling Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 11-3-21 Drug How CEP holders can avoid the rejection of notifications Registration Visit Page
Australia Therapeutic Goods Administration 10-3-21 Vaccine COVID-19 vaccines - safety and effectiveness in older adults Safety Visit Page
India Central Drugs Standard Control Organisation 10-3-21 Vaccine Recommendations of the SEC meeting to examine COVID-19 related proposal under accelerated approval process Registration Visit Page
Europe European Commission 10-3-21 Vaccine "Guidance on state of the art of COVID-19 rapid antibody tests" General Visit Page
UK Medicines and Healthcare products Regulatory Agency 9-3-21 Drug Importing medicines into Northern Ireland before 31 December 2021 Regulatory Visit Page
Ireland Health Products Regulatory Authority 9-3-21 Drug Good Distribution Practice of Medicinal Products for Human Use General Visit Page
Ireland Health Products Regulatory Authority 9-3-21 Drug-Device Combination "Guide to New Applications and Variations to Wholesale Distribution Authorisations" Regulatory Visit Page
Australia Therapeutic Goods Administration 9-3-21 Medical Device IMDRF consultation: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews Registration Visit Page
Europe European Commission 5-3-21 Drug Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004 Registration Visit Page
UK Medicines and Healthcare products Regulatory Agency 4-3-21 Vaccine Guidance on strain changes in authorised COVID-19 vaccines General Visit Page
USA Food and Drug Administration 4-3-21 Vaccine COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers Regulatory Visit Page
USA Food and Drug Administration 3-3-21 Data Modernization Action Plan Regulatory Visit Page
Europe European Medicines Agency 3-3-21 Drug EMA issues advice on use of antibody combination (bamlanivimab / etesevimab) General Visit Page
Europe European Commission 3-3-21 Drug "Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices" General Visit Page
Malaysia National Pharmaceutical Regulatory Agency 1-3-21 Drug Guidance Notes Updated API information for product registration Regulatory Visit Page
Europe European Directorate for the Quality of Medicines and Healthcare 1-3-21 Drug Revision of CEPs referring to one of the "sartan” monographs following their rapid implementation Regulatory Visit Page
UK Medicines and Healthcare products Regulatory Agency 26-2-21 Drug First Innovation Passport awarded to help support development and access to cutting-edge medicines Registration Visit Page
Australia Therapeutic Goods Administration 26-2-21 Medical Device Consultation: Proposed regulatory options for medical devices containing nanomaterials (for comments) Regulatory Visit Page
Australia Therapeutic Goods Administration 25-2-21 Medical Device Regulatory changes for software based medical devices Registration Visit Page
Australia Therapeutic Goods Administration 24-2-21 Drug-Device Combination The TGA's risk management approach Safety Visit Page
Europe European Medicines Agency 23-2-21 Vaccine "Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2" Registration Visit Page
USA Food and Drug Administration 22-2-21 Drug-Device Combination FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants General Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Europe European Medicines Agency 22-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
USA Food and Drug Administration 19-2-21 Medical Device Pulse Oximeter Accuracy and Limitations: FDA Safety Communication Safety Visit Page
Malaysia National Pharmaceutical Regulatory Agency 18-2-21 Drug-Device Combination Guidance Document Foreign GMP Inspection General Visit Page
UK Medicines and Healthcare products Regulatory Agency 17-2-21 Drug-Device Combination How investigators and sponsors should manage clinical trials during COVID-19 General Visit Page
USA Food and Drug Administration 16-2-21 Medical Device "Medical Device User Fees; Stakeholder Meetings on Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization; Request for Notification of Stakeholder Intention to Participate" General Visit Page
Europe European Commission 15-2-21 Medical Device Management of Legacy Devices MDR EUDAMED General Visit Page
India National Pharmaceutical Pricing Authority 12-2-21 Drug Application for retail price fixation of new drugs through email only General Visit Page
Europe European Medicines Agency 11-2-21 Drug-Device Combination Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe Regulatory Visit Page
Denmark Danish Medicines Agency 10-2-21 Vaccine Danish Medicines Agency expands capacity for safety monitoring of Covid-19 vaccines Safety Visit Page
UK Medicines and Healthcare products Regulatory Agency 9-2-21 Drug Access New Active Substance (NAS) Work Sharing Initiative General Visit Page
USA Food and Drug Administration 4-2-21 Vaccine FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data Labeling Visit Page
Europe European Medicines Agency 4-2-21 Drug Guidance on the management of clinical trials during the Covid-19 (coronavirus) pandemic Clinical Visit Page
Europe European Medicines Agency 3-2-21 Drug Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 3 of Module XVI on risk minimization measures and its Addendum II on methods for their effectiveness evaluation for public consultation Safety Visit Page
Europe European Medicines Agency 3-2-21 Drug "Questions and Answers on the Pilot Project 'OPEN' - Opening our Procedures at EMA to Non-EU authorities" Registration Visit Page
International World Health Organization 3-2-21 Drug WHO announces updated critical concentrations for susceptibility testing to rifampicin General Visit Page
Europe European Medicines Agency 2-2-21 Drug Draft toolbox guidance on scientific elements and 5 regulatory tools to support quality data packages for 6 PRIME marketing authorization applications Registration Visit Page
Australia Therapeutic Goods Administration 1-2-21 Drug Safety advisory - enhanced warnings relating Safety advisory - enhanced warnings relating Labeling Visit Page
UK Medicines and Healthcare products Regulatory Agency 1-2-21 Drug Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) Safety Visit Page
Australia Therapeutic Goods Administration 1-2-21 Drug Repurposing of Prescription Medicines Labeling Visit Page
Australia Therapeutic Goods Administration 1-2-21 Drug Fees and charges proposal 2021-22 Registration Visit Page
Europe European Medicines Agency 1-2-21 Drug Nitrosamine impurity check extends to Rifampicin Labeling Visit Page
Australia Therapeutic Goods Administration 1-2-21 Vaccine COVID-19 vaccine safety monitoring plan Safety Visit Page
USA Food and Drug Administration 1-2-21 Medical Device Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests Clinical Visit Page
USA Food and Drug Administration 1-2-21 Vaccine Guidance for Industry - Development of Monoclonal Antibody Products Targeting SARSCoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency Clinical Visit Page
USA Food and Drug Administration 1-2-21 Vaccine COVID-19: Developing Drugs and Biological Products for Treatment or Prevention Clinical Visit Page
Europe European Commission 1-2-21 Medical Device "Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional" Registration Visit Page
USA Food and Drug Administration 1-2-21 Drug 2020 CDER Annual Report General Visit Page
Australia Therapeutic Goods Administration 29-1-21 Medical Device Emergency COVID-19 exemptions end for ventilators and personal protective equipment General Visit Page
USA Food and Drug Administration 29-1-21 Drug Manufacturing, Supply Chain, and Drug Inspections - COVID-19 CMC 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

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

Australia

Date of Publishing

15-11-22

Product Type

Medical Device

Topic

Post-market review of ventilators, CPAP and BiPAP devices

Domain

Pharmacovigilance

URL

Country/Region

UK

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

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

18-10-22

Product Type

Drug

Topic

ANDA Submissions – Prior Approval Supplements Under GDUFA

Domain

Regulatory

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

Australia

Date of Publishing

17-10-22

Product Type

Drug

Topic

Pharmacovigilance Inspection Program Risk Assessment Survey

Domain

Pharmacovigilance

URL

Country/Region

USA

Date of Publishing

17-10-22

Product Type

Drug

Topic

Tissue Agnostic Drug Development in Oncology

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

17-10-22

Product Type

Drug

Topic

Characterizing, Collecting, and Reporting Immune-Mediated Adverse Reactions in Cancer Immunotherapeutic Clinical Trials

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

17-10-22

Product Type

Drug

Topic

Acute Myeloid Leukemia: Developing Drugs and Biological Products for Treatment

Domain

Clinical

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

USA

Date of Publishing

14-10-22

Product Type

Drug

Topic

Comparability Protocols for Post approval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA

Domain

CMC

URL

Country/Region

USA

Date of Publishing

12-10-22

Product Type

Drug

Topic

Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

11-10-22

Product Type

Medical Device

Topic

Classification of medical device pertaining to oncology under the provisions of medical devices rules, 2017

Domain

Regulatory

URL

Country/Region

Denmark

Date of Publishing

11-10-22

Product Type

Drug

Topic

Current Danish QRD template to be used in connection with the granting of marketing authorizations

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

7-10-22

Product Type

Drug

Topic

GMP approach to overseas manufacturers of medicines and biologicals during the COVID-19 pandemic

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

7-10-22

Product Type

Drug

Topic

Boundary and combination products guidance - medicines, medical devices, and biologicals

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

7-10-22

Product Type

Medical Device

Topic

Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

6-10-22

Product Type

Medical Device

Topic

Post market Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act

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

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

The Philippines

Date of Publishing

3-10-22

Product Type

Drug

Topic

Amendment to Administrative Order No. 2020-0017 entitled, “Revised Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2016-0003” (Draft guidance)

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

3-10-22

Product Type

Drug

Topic

National list of Essential Medicines 2022

Domain

Regulatory

URL

Country/Region

Japan

Date of Publishing

3-10-22

Product Type

Drug

Topic

PDG Welcomes Indian Pharmacopoeia Commission to Pilot for Global Expansion

Domain

Regulatory

URL

Country/Region

Ireland

Date of Publishing

1-10-22

Product Type

Drug

Topic

Public Consultation on Annual Review and Proposal for Fees – Financial Year 2023

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

30-9-22

Product Type

Drug

Topic

Data Quality Framework for EU medicines regulation

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

30-9-22

Product Type

Drug

Topic

European Commission Decision Reliance Procedure (EC DRP) extension

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

30-9-22

Product Type

Medical Device

Topic

Regulation of all Class A & B Medical Devices under Licensing regime

Domain

Regulatory

URL

Country/Region

Global

Date of Publishing

29-9-22

Product Type

Drug

Topic

Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin Q5A(R2)

Domain

Safety

URL

Country/Region

UK

Date of Publishing

29-9-22

Product Type

Medical Device

Topic

MHRA appoints first new UK Approved Body to certify medical devices since Brexit

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

29-9-22

Product Type

Drug

Topic

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

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

28-9-22

Product Type

Drug

Topic

User experience survey - Database of Adverse Event Notifications (DAEN) – medicines beta version

Domain

Safety

URL

Country/Region

USA

Date of Publishing

28-9-22

Product Type

Medical Device

Topic

Display Devices for Diagnostic Radiology

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-9-22

Product Type

Medical Device

Topic

Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-9-22

Product Type

Medical Device

Topic

Clinical Decision Support Software

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-9-22

Product Type

Medical Device

Topic

Policy for Device Software Functions and Mobile Medical Applications

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-9-22

Product Type

Drug

Topic

Protection of Human Subjects and Institutional Review Boards

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

28-9-22

Product Type

Vaccine

Topic

Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (Revised); Immediately in Effect Guidance for Commercial Manufacturers and Food and Drug Administration Staff; Availability

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

Global

Date of Publishing

27-9-22

Product Type

Drug

Topic

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

Domain

Safety

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

USA

Date of Publishing

23-9-22

Product Type

Drug

Topic

New FDA Draft Guidance Aims to Protect Children who Participate in Clinical Trials

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

22-9-22

Product Type

Medical Device

Topic

Electronic Submission Template for Medical Device 510(k) Submissions

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

19-9-22

Product Type

Biologics

Topic

Biosimilar medicines can be interchanged

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

14-9-22

Product Type

Drug

Topic

Potential nitrosamine contamination – harmonised implementation (update)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

14-9-22

Product Type

Drug

Topic

Independent review of paracetamol overdose

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

14-9-22

Product Type

Medical Device

Topic

MDCG 2022-15 - Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

14-9-22

Product Type

Medical Device

Topic

MDCG 2021-22 rev.1 - Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

14-9-22

Product Type

Drug

Topic

Annual Summary Reporting Requirements Under the Right to Try Act

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

14-9-22

Product Type

Medical Device

Topic

SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests

Domain

Regulatory

URL

Country/Region

Japan

Date of Publishing

13-9-22

Product Type

Drug

Topic

Labeling of Codes on Containers to Identify Regenerative Medical Products, etc

Domain

Labeling

URL

Country/Region

Japan

Date of Publishing

13-9-22

Product Type

Drug

Topic

Labeling of Codes on Containers to Identify Prescription Drugs

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

13-9-22

Product Type

Drug

Topic

Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List Under the 21st Century Cures Act

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

13-9-22

Product Type

Medical Device

Topic

Computer Software Assurance for Production and Quality System Software (draft guidance)

Domain

Regulatory

URL

Country/Region

India

Date of Publishing

9-9-22

Product Type

Medical Device

Topic

Classification of non-sterile, non-powered, hand-held, or hand-manipulated surgical instruments for general use intended to be used in surgical procedures

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

8-9-22

Product Type

Medical Device

Topic

Medical devices - reclassification of products without an intended medical purpose

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

7-9-22

Product Type

Medical Device

Topic

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

7-9-22

Product Type

Drug

Topic

Policy for Monkeypox Tests to Address the Public Health Emergency, Guidance for Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

2-9-22

Product Type

Drug

Topic

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 29 August – 1 September 2022

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

1-9-22

Product Type

Drug

Topic

Good Practice Guide for the use of the Metadata Catalogue of Real-World Data Sources

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-9-22

Product Type

Drug

Topic

Providing Over-the-Counter Monograph Submissions in Electronic Format (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-9-22

Product Type

Drug

Topic

Ethical Considerations for Clinical Investigations of Medical Products Involving Children

Domain

Clinical

URL

Country/Region

Malaysia

Date of Publishing

1-9-22

Product Type

Medical Device

Topic

Guideline for re-registration of registered medical device

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-9-22

Product Type

Drug

Topic

Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-9-22

Product Type

Drug

Topic

Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over the Counter and Prescription Drug Products

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-9-22

Product Type

Drug

Topic

Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products (draft guidance)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

1-9-22

Product Type

Drug

Topic

General Clinical Pharmacology Considerations for Pediatric Studies of Drugs, Including Biological Products Guidance for Industry

Domain

Pharmacovigilance

URL

Country/Region

UK

Date of Publishing

1-9-22

Product Type

Drug

Topic

Canada - United Kingdom Trade Continuity Agreement Protocol for Recognition of Good Manufacturing Practices

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-9-22

Product Type

Drug

Topic

Consultation: Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings, November 2022

Domain

Safety

URL

Country/Region

UK

Date of Publishing

31-8-22

Product Type

Drug

Topic

Consultation on proposals for changes to the Medicines and Healthcare products Regulatory Agency’s statutory fees

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

30-8-22

Product Type

Medical Device

Topic

Licensing for establishment

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

26-8-22

Product Type

Medical Device

Topic

MDCG 2022-14 - Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

25-8-22

Product Type

Medical Device

Topic

evision - Manufacture of Sterile Medicinal Products

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

23-8-22

Product Type

Drug

Topic

Ph. Eur. survey for the availability of alternative plasticisers to DEHP in containers for aqueous solutions for intravenous infusion in authorised medicinal products

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

23-8-22

Product Type

Drug

Topic

Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft for comments)

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

17-8-22

Product Type

Medical Device

Topic

Exemption for Certain Clinical Decision Support Software

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

17-8-22

Product Type

Medical Device

Topic

Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

17-8-22

Product Type

Medical Device

Topic

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

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

17-8-22

Product Type

Medical Device

Topic

Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

17-8-22

Product Type

Medical Device

Topic

Regulation of software based medical devices

Domain

Regulatory

URL

Country/Region

Singapore

Date of Publishing

12-8-22

Product Type

Medical Device

Topic

Potential increase of mortality and amputation risk associated with paclitaxel-coated devices

Domain

Safety

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

International

Date of Publishing

4-8-22

Product Type

Drug

Topic

Testing for carcinogenicity of pharmaceuticals

Domain

Safety

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

USA

Date of Publishing

3-8-22

Product Type

Medical Device

Topic

Sterilization for Medical Devices

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

1-8-22

Product Type

Drug

Topic

Regulatory options to potentially allow references to the TGA in therapeutic goods advertising

Domain

Labeling

URL

Country/Region

Malaysia

Date of Publishing

1-8-22

Product Type

Medical Device

Topic

Harmonized classification of medical devices in ASEAN

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-8-22

Product Type

Drug

Topic

Charging for Investigational Drugs Under an IND Questions and Answers Guidance for Industry (draft guidance)

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

UK to strengthen regulation of medical devices to protect patients

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

27-6-22

Product Type

Drug

Topic

Nonprescription Drug Product with an Additional Condition for Nonprescription Use

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

27-6-22

Product Type

Drug

Topic

Outcome of the consultation on the proposed warning and advisory statements relating to harm of long-term use and overuse of stimulant laxatives

Domain

Labeling

URL

Country/Region

Australia

Date of Publishing

27-6-22

Product Type

Medical Device

Topic

Clinical evidence guidelines for medical devices

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

24-6-22

Product Type

Drug

Topic

Considerations for the Development of Oligonucleotide Therapeutics (draft guidance)

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

The Philippines

Date of Publishing

23-6-22

Product Type

Drug

Topic

Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price (MRP)

Domain

Labeling

URL

Country/Region

USA

Date of Publishing

23-6-22

Product Type

Drug

Topic

Non-Penicillin Beta-Lactam Drugs: A CGMP Framework for Preventing Cross-Contamination (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

23-6-22

Product Type

Drug

Topic

Assessing the Effects of Food on Drugs in Investigational New Drugs and New Drug Applications—Clinical Pharmacology Considerations

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

23-6-22

Product Type

Drug and Biological Product

Topic

Considerations for Rescinding Breakthrough Therapy Designation

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

Ireland

Date of Publishing

15-6-22

Product Type

Medical Device

Topic

Guide to Performance Studies Conducted in Ireland

Domain

Clinical

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

Malaysia

Date of Publishing

8-6-22

Product Type

Medical Device

Topic

Guideline for re-registration of registered medical device

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

7-6-22

Product Type

Medical Device

Topic

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices--Questions and Answers (Revised); Withdrawal of Guidance

Domain

Regulatory

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

USA

Date of Publishing

6-6-22

Product Type

Medical Device

Topic

Gastroenterology-Urology Devices; Classification of the Non-Implanted Electrical Stimulation Device for Management of Premature Ejaculation

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

Europe

Date of Publishing

2-6-22

Product Type

Drug

Topic

Questions and answers - Complex clinical trials

Domain

Clinical

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

The Philippines

Date of Publishing

1-6-22

Product Type

Drug

Topic

Implementing Guidelines on the Collaborative Procedure for the Accelerated Registration of World Health Organization (WHO) – Prequalified Pharmaceutical Products and Vaccines

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

1-6-22

Product Type

Medical Device

Topic

Classification of the Coronary Artery Disease Risk Indicator Using Acoustic Heart Signals

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-6-22

Product Type

Medical Device

Topic

Draft standardization request amending Implementing Decision C (2021) 2406 of 14.4.2021

Domain

Regulatory

URL

Country/Region

Switzerland

Date of Publishing

1-6-22

Product Type

Drug

Topic

Applications for clinical trials for medicinal products

Domain

Clinical

URL

Country/Region

Ireland

Date of Publishing

30-5-22

Product Type

Drug

Topic

Stakeholder Consultation on Registration of Processes exempted under Article 61(5) and applicable requirements under Article 61(6) of the CTR

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

27-5-22

Product Type

Medical Device

Topic

Seasonal Influenza Rapid Antigen Self-tests and Combination tests Clinical performance requirements and risk mitigation strategies

Domain

Clinical

URL

Country/Region

Switzerland

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

25-5-22

Product Type

Medical Device

Topic

Procedure for Remote Inspection as a Part of Compliance Inspection on Drugs and Regenerative Medical Products

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

20-5-22

Product Type

Drug

Topic

Product-Specific Guidance’s; Draft and Revised Draft Guidance’s for Industry; Availability

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

19-5-22

Product Type

Drug

Topic

Addendum to the guideline on the evaluation of medicinal products indicated for treatment of bacterial infections to address pediatric-specific clinical data requirements

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

19-5-22

Product Type

Drug

Topic

Guideline on the evaluation of medicinal products indicated for treatment of bacterial infections

Domain

Clinical

URL

Country/Region

India

Date of Publishing

18-5-22

Product Type

Medical Device

Topic

Suspension and cancellation of medical device licenses

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

18-5-22

Product Type

Drug

Topic

Ph. Eur. Commission adopts first “horizontal standard” for monoclonal antibodies

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

16-5-22

Product Type

Drug

Topic

PIC/S work plan for 2022

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

11-5-22

Product Type

Medical Device

Topic

Amending Implementing Decision (EU) 2021/1182 as regards harmonized standards for quality management systems, sterilization, and application of risk management to medical devices

Domain

Quality

URL

Country/Region

Europe

Date of Publishing

11-5-22

Product Type

Drug

Topic

Public Consultation Concerning the Physical Attendance and The Location of Personal Residency of The Qualified Person

Domain

Pharmacovigilance

URL

Country/Region

Europe

Date of Publishing

10-5-22

Product Type

Drug

Topic

Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

9-5-22

Product Type

Drug

Topic

Independent expert report on the risks of intentional self-poisoning with paracetamol

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

6-5-22

Product Type

Medical Device

Topic

Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program (draft guidance)

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

5-5-22

Product Type

Drug

Topic

Good Clinical Practice (GCP) inspection procedures – annexures updated

Domain

Clinical

URL

Country/Region

Australia

Date of Publishing

4-5-22

Product Type

Drug

Topic

Update to Manufacturing Principles for medicines, APIs & sunscreens

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

4-5-22

Product Type

Medical Device

Topic

MDCG 2022-6 - Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

4-5-22

Product Type

Drug

Topic

FDA Permits Marketing for New Test to Improve Diagnosis of Alzheimer’s Disease

Domain

Regulatory

URL

Country/Region

Denmark

Date of Publishing

3-5-22

Product Type

Drug

Topic

New executive order raises fees in the area of the Danish Medicines Agency

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

2-5-22

Product Type

Drug

Topic

Updated Guidelines on the Unified Licensing Requirements and Procedures of the Food and Drug Administration Repealing Administrative Order No. 2020-0017

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Importation of Prescription Drugs Final Rule Questions and Answers

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

2-5-22

Product Type

Drug

Topic

Guidelines on Regulatory Reliance on the Conduct of Clinical Trials in the Philippines (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Biologics

Topic

Compliance Policy Regarding Blood and Blood Component Donation Suitability, Donor Eligibility and Source Plasma Quarantine Hold Requirements (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Biologics

Topic

Blood Pressure and Pulse Donor Eligibility Requirements – Compliance Policy (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Biologics

Topic

Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Components

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

2-5-22

Product Type

Medical Device

Topic

MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors

Domain

Safety

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Risk Management Plans to Mitigate the Potential for Drug Shortages (draft guidance)

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production

Domain

Regulatory

URL

Country/Region

The Philippines

Date of Publishing

2-5-22

Product Type

Medical Device

Topic

Good Storage and Distribution Practices for Medical Devices (draft guidance)

Domain

Regulatory

URL

Country/Region

New Zealand

Date of Publishing

2-5-22

Product Type

Drug

Topic

Review of Fees payable under the Medicines Act 1981

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Benefit-Risk Considerations for Product Quality Assessments (draft guidance)

Domain

CMC

URL

Country/Region

USA

Date of Publishing

2-5-22

Product Type

Drug

Topic

Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies Guidance for Industry (draft guidance)

Domain

Clinical

URL

Country/Region

Switzerland

Date of Publishing

2-5-22

Product Type

Drug

Topic

Questions and answers on the packaging and labelling requirements for medicinal products intended to prevent or combat COVID-19

Domain

Labeling

URL

Country/Region

Australia

Date of Publishing

29-4-22

Product Type

Drug

Topic

Proposed amendments to the Poisons Standard – ACCS, ACMS and joint ACCS/ACMS meetings

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

29-4-22

Product Type

Drug

Topic

Crohn’s Disease: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

29-4-22

Product Type

Drug

Topic

Ulcerative Colitis: Developing Drugs for Treatment (draft guidance)

Domain

Clinical

URL

Country/Region

India

Date of Publishing

28-4-22

Product Type

Drug

Topic

Procedure for regularization of FDCs

Domain

Regulatory

URL

Country/Region

Malaysia

Date of Publishing

1-4-22

Product Type

Medical Device

Topic

Guidance on the rules of classification for general medical devices

Domain

Regulatory

URL

Country/Region

International

Date of Publishing

31-3-22

Product Type

Drug

Topic

Considerations with respect to future MIDD related guidelines - output from ich model-informed drug development (MIDD)

Domain

Regulatory

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

3-2-22

Product Type

Vaccine

Topic

Amendment to FDA Circular No. 2020-029 entitled “Guidance on Applications for the Conduct of COVID-19 Clinical Trials

Domain

Clinical

URL

Country/Region

New Zealand

Date of Publishing

15-4-21

Product Type

Drug

Topic

Outcome of the consultation on the proposed changes to paracetamol warning and advisory statements

Domain

Labeling

URL

Country/Region

Switzerland

Date of Publishing

1-4-21

Product Type

Medical Device

Topic

New requirements and changes to authorisation practice as of May 2021

Domain

Registration

URL

Country/Region

USA

Date of Publishing

25-3-21

Product Type

Drug

Topic

Upcoming Product-Specific Guidances for Complex Generic Drug Product Development

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

24-3-21

Product Type

Vaccine

Topic

New procedure to facilitate and speed up approval of adapted vaccines against Covid-19 variants

Domain

Registration

URL

Country/Region

UK

Date of Publishing

23-3-21

Product Type

Drug-Device Combination

Topic

MHRA pilots patient involvement in new applications

Domain

Registration

URL

Country/Region

The Philippines

Date of Publishing

23-3-21

Product Type

Vaccine

Topic

Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection

Domain

Registration

URL

Country/Region

UK

Date of Publishing

19-3-21

Product Type

Drug-Device Combination

Topic

Guidance for industry on MHRA's expectations for return to UK on-site inspections

Domain

General

URL

Country/Region

Europe

Date of Publishing

17-3-21

Product Type

Drug

Topic

Rapid implementation of the revised sartan monographs on 1 April 2021

Domain

Registration

URL

Country/Region

USA

Date of Publishing

17-3-21

Product Type

Topic

FDA Permits Marketing of First SARS-CoV-2 Diagnostic Test Using Traditional Premark Review Process

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

17-3-21

Product Type

Drug

Topic

SWP response to CMDh questions on chlorobutanol

Domain

General

URL

Country/Region

USA

Date of Publishing

16-3-21

Product Type

Medical Device

Topic

Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

15-3-21

Product Type

Vaccine

Topic

EMA's safety committee continues investigation of COVID-19 Vaccine AstraZeneca and thromboembolic events – further update

Domain

Safety

URL

Country/Region

India

Date of Publishing

12-3-21

Product Type

Medical Device

Topic

Change in medical device pricing

Domain

General

URL

Country/Region

Europe

Date of Publishing

12-3-21

Product Type

Vaccine

Topic

Labelling flexibilities for COVID-19 therapeutics

Domain

Labeling

URL

Country/Region

Canada

Date of Publishing

12-3-21

Product Type

Drug

Topic

"Electronic media in prescription drug labelling"

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

11-3-21

Product Type

Drug

Topic

How CEP holders can avoid the rejection of notifications

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

10-3-21

Product Type

Vaccine

Topic

COVID-19 vaccines - safety and effectiveness in older adults

Domain

Safety

URL

Country/Region

India

Date of Publishing

10-3-21

Product Type

Vaccine

Topic

Recommendations of the SEC meeting to examine COVID-19 related proposal under accelerated approval process

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

10-3-21

Product Type

Vaccine

Topic

"Guidance on state of the art of COVID-19 rapid antibody tests"

Domain

General

URL

Country/Region

UK

Date of Publishing

9-3-21

Product Type

Drug

Topic

Importing medicines into Northern Ireland before 31 December 2021

Domain

Regulatory

URL

Country/Region

Ireland

Date of Publishing

9-3-21

Product Type

Drug

Topic

Good Distribution Practice of Medicinal Products for Human Use

Domain

General

URL

Country/Region

Ireland

Date of Publishing

9-3-21

Product Type

Drug-Device Combination

Topic

"Guide to New Applications and Variations to Wholesale Distribution Authorisations"

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

9-3-21

Product Type

Medical Device

Topic

IMDRF consultation: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

5-3-21

Product Type

Drug

Topic

Handling of duplicate marketing authorisation applications of pharmaceutical products under Article 82(1) of Regulation (EC) No 726/2004

Domain

Registration

URL

Country/Region

UK

Date of Publishing

4-3-21

Product Type

Vaccine

Topic

Guidance on strain changes in authorised COVID-19 vaccines

Domain

General

URL

Country/Region

USA

Date of Publishing

4-3-21

Product Type

Vaccine

Topic

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

3-3-21

Product Type

Topic

Data Modernization Action Plan

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

3-3-21

Product Type

Drug

Topic

EMA issues advice on use of antibody combination (bamlanivimab / etesevimab)

Domain

General

URL

Country/Region

Europe

Date of Publishing

3-3-21

Product Type

Drug

Topic

"Questions and Answers on Custom-Made Devices & considerations on Adaptable medical devices and Patient-matched medical devices"

Domain

General

URL

Country/Region

Malaysia

Date of Publishing

1-3-21

Product Type

Drug

Topic

Guidance Notes Updated API information for product registration

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

1-3-21

Product Type

Drug

Topic

Revision of CEPs referring to one of the "sartan” monographs following their rapid implementation

Domain

Regulatory

URL

Country/Region

UK

Date of Publishing

26-2-21

Product Type

Drug

Topic

First Innovation Passport awarded to help support development and access to cutting-edge medicines

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

26-2-21

Product Type

Medical Device

Topic

Consultation: Proposed regulatory options for medical devices containing nanomaterials (for comments)

Domain

Regulatory

URL

Country/Region

Australia

Date of Publishing

25-2-21

Product Type

Medical Device

Topic

Regulatory changes for software based medical devices

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

24-2-21

Product Type

Drug-Device Combination

Topic

The TGA's risk management approach

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

23-2-21

Product Type

Vaccine

Topic

"Reflection paper on the regulatory requirements for vaccines intended to provide protection against variant strain(s) of SARS-CoV-2"

Domain

Registration

URL

Country/Region

USA

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

Domain

General

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Europe

Date of Publishing

22-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

USA

Date of Publishing

19-2-21

Product Type

Medical Device

Topic

Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

Domain

Safety

URL

Country/Region

Malaysia

Date of Publishing

18-2-21

Product Type

Drug-Device Combination

Topic

Guidance Document Foreign GMP Inspection

Domain

General

URL

Country/Region

UK

Date of Publishing

17-2-21

Product Type

Drug-Device Combination

Topic

How investigators and sponsors should manage clinical trials during COVID-19

Domain

General

URL

Country/Region

USA

Date of Publishing

16-2-21

Product Type

Medical Device

Topic

"Medical Device User Fees; Stakeholder Meetings on Medical Device User Fee Amendments of Fiscal Years 2023 to 2027 Reauthorization; Request for Notification of Stakeholder Intention to Participate"

Domain

General

URL

Country/Region

Europe

Date of Publishing

15-2-21

Product Type

Medical Device

Topic

Management of Legacy Devices MDR EUDAMED

Domain

General

URL

Country/Region

India

Date of Publishing

12-2-21

Product Type

Drug

Topic

Application for retail price fixation of new drugs through email only

Domain

General

URL

Country/Region

Europe

Date of Publishing

11-2-21

Product Type

Drug-Device Combination

Topic

Products Management Services - Implementation of International Organization for Standardization (ISO) standards for the identification of medicinal products (IDMP) in Europe

Domain

Regulatory

URL

Country/Region

Denmark

Date of Publishing

10-2-21

Product Type

Vaccine

Topic

Danish Medicines Agency expands capacity for safety monitoring of Covid-19 vaccines

Domain

Safety

URL

Country/Region

UK

Date of Publishing

9-2-21

Product Type

Drug

Topic

Access New Active Substance (NAS) Work Sharing Initiative

Domain

General

URL

Country/Region

USA

Date of Publishing

4-2-21

Product Type

Vaccine

Topic

FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma to Reflect New Data

Domain

Labeling

URL

Country/Region

Europe

Date of Publishing

4-2-21

Product Type

Drug

Topic

Guidance on the management of clinical trials during the Covid-19 (coronavirus) pandemic

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

3-2-21

Product Type

Drug

Topic

Guidelines on good pharmacovigilance practices (GVP) Introductory cover note, last updated with revision 3 of Module XVI on risk minimization measures and its Addendum II on methods for their effectiveness evaluation for public consultation

Domain

Safety

URL

Country/Region

Europe

Date of Publishing

3-2-21

Product Type

Drug

Topic

"Questions and Answers on the Pilot Project 'OPEN' - Opening our Procedures at EMA to Non-EU authorities"

Domain

Registration

URL

Country/Region

International

Date of Publishing

3-2-21

Product Type

Drug

Topic

WHO announces updated critical concentrations for susceptibility testing to rifampicin

Domain

General

URL

Country/Region

Europe

Date of Publishing

2-2-21

Product Type

Drug

Topic

Draft toolbox guidance on scientific elements and 5 regulatory tools to support quality data packages for 6 PRIME marketing authorization applications

Domain

Registration

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drug

Topic

Safety advisory - enhanced warnings relating Safety advisory - enhanced warnings relating

Domain

Labeling

URL

Country/Region

UK

Date of Publishing

1-2-21

Product Type

Drug

Topic

Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

Domain

Safety

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drug

Topic

Repurposing of Prescription Medicines

Domain

Labeling

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Drug

Topic

Fees and charges proposal 2021-22

Domain

Registration

URL

Country/Region

Europe

Date of Publishing

1-2-21

Product Type

Drug

Topic

Nitrosamine impurity check extends to Rifampicin

Domain

Labeling

URL

Country/Region

Australia

Date of Publishing

1-2-21

Product Type

Vaccine

Topic

COVID-19 vaccine safety monitoring plan

Domain

Safety

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Medical Device

Topic

Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Vaccine

Topic

Guidance for Industry - Development of Monoclonal Antibody Products Targeting SARSCoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency

Domain

Clinical

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Vaccine

Topic

COVID-19: Developing Drugs and Biological Products for Treatment or Prevention

Domain

Clinical

URL

Country/Region

Europe

Date of Publishing

1-2-21

Product Type

Medical Device

Topic

"Guidance on harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional"

Domain

Registration

URL

Country/Region

USA

Date of Publishing

1-2-21

Product Type

Drug

Topic

2020 CDER Annual Report

Domain

General

URL

Country/Region

Australia

Date of Publishing

29-1-21

Product Type

Medical Device

Topic

Emergency COVID-19 exemptions end for ventilators and personal protective equipment

Domain

General

URL

Country/Region

USA

Date of Publishing

29-1-21

Product Type

Drug

Topic

Manufacturing, Supply Chain, and Drug Inspections - COVID-19

Domain

CMC

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

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