Navigate the Regulatory Landscape
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Keep pace with the dynamic regulatory environment through regular updates provided by ClinChoice. Utilize our comprehensive references to stay abreast of regulatory changes across a spectrum of medical topics from health authorities across the globe.

Country/Region Health Authority Date of Publishing Product Type Topic Domain URL
USA Food and Drug Administration 06-01-26 Drug Over-The-Counter Monograph Drug User Fee Program (OMUFA) Regulatory View Page
USA Food and Drug Administration 03-12-25 Drug Monoclonal Antibodies: Streamlined Nonclinical Safety Studies (draft) Non-Clinical View Page
Switzerland The Swiss Agency for Therapeutic Products 01-12-25 Drug Changes to the Guidance document Packaging for human medicinal products Packaging View Page
Malaysia National Pharmaceutical Regulatory Agency 30-11-25 Drug NPRA GLP Compliance Programme – Frequently Asked Questions (FAQ) Compliance View Page
Europe European Medicines Agency 27-11-25 Drug Medicines are not sweets: European campaign promoting responsible use of over-the-counter medicines Regulatory View Page
Europe European Commission 27-11-25 Medical Device The EUDAMED four first modules will be mandatory to use as from 28 May 2026 Regulatory View Page
USA Food and Drug Administration 25-11-25 Drug FDA Approves Reformulated Ranitidine Regulatory View Page
Australia Therapeutic Goods Administration 24-11-25 Drug Adoption of International Scientific Guidelines in Australia R01-2025 Regulatory View Page
USA Food and Drug Administration 21-11-25 Medical Device CDRH Proposed Guidance’s for Fiscal Year 2026 (FY2026) Regulatory View Page
USA Food and Drug Administration 21-11-25 Drug Product-Specific Guidances; Draft and Revised Draft Guidances for Industry; Availability Clinical View Page
India Central Drugs Standard Control Organisation 20-11-25 Drug Adverse reaction reporting Pharmacovigilance View Page
USA Food and Drug Administration 19-11-25 Drug FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies Labeling View Page
USA Food and Drug Administration 17-11-25 Drug Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use; Guidance for Industry; Availability Regulatory View Page
India Central Drugs Standard Control Organisation 17-11-25 Medical Device Indian license mandatory for procurement agencies to buy medical device Regulatory View Page
Switzerland The Swiss Agency for Therapeutic Products 17-11-25 Drug Guidance for stepwise PIPs (sPIPs) Regulatory View Page
Europe European Medicines Agency 13-11-25 Drug Guideline on non-inferiority and equivalence comparisons 5 in clinical trials (draft) Clinical View Page
Japan Pharmaceuticals and Medical Devices Agency 13-11-25 Drug Points to Consider for Clinical Development of Drugs Intended for Treatment of Psoriatic Arthritis (Early Consideration） Clinical View Page
Europe European Medicines Agency 12-11-25 Drug Guidance for applicants: the ETF scientific advice that facilitates clinical trial authorisations (SA-CTA) Clinical View Page
Malaysia Medical Device Authority 11-11-25 Medical Device Implementation of validity period for product classification letter Regulatory View Page
Europe European Commission 10-11-25 Drug Pilot coordinated assessment for CI/PS Clinical View Page
China National Medical Products Administration 07-11-25 Medical Device Revision and Release of the Good Manufacturing Practice for Medical Devices Regulatory View Page
Malaysia Medical Device Authority 07-11-25 Medical Device Registration Status of MEDCERT MALAYSIA SDN. BHD. as a Conformity Assessment Body (cab) under act 737 date of announcement: 7 November 2025 Regulatory View Page
USA Food and Drug Administration 06-11-25 Drug How to Prepare a Pre-Request for Designation (Pre-RFD) Regulatory View Page
Australia Therapeutic Goods Administration 05-11-25 Drug TGA releases updated social media advertising guidance to support improved compliance Regulatory View Page
UK Medicines and Healthcare products Regulatory Agency 02-11-25 Drug Major change for rare disease treatments on way, signals MHRA Regulatory View Page

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