Navigate the Regulatory Landscape
& Make Smart Decisions
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 |
|---|---|---|---|---|---|---|
| Malaysia | National Pharmaceutical Regulatory Agency | 30-11-25 | Drug | NPRA GLP Compliance Programme – Frequently Asked Questions (FAQ) | Compliance | 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 |
| 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 |
| UK | Medicines and Healthcare products Regulatory Agency | 01-11-25 | Drug | Replacing animals in science: A strategy to support the development, validation and uptake of alternative methods | Non-Clinical | View Page |
| USA | Food and Drug Administration | 01-11-25 | Drug | Cross-Center Master Files: Where to Submit (draft) | Regulatory | View Page |
| Europe | European Commission | 01-11-25 | Medical Device | Guidance on the implementation of the Master UDI-DI solution for spectacle frames, spectacle lenses and ready-to-wear reading spectacles | Regulatory | View Page |
| USA | Food and Drug Administration | 31-10-25 | Drug | FDA Acts to Protect Children from Unapproved Fluoride Drug Products | Safety | View Page |
| USA | Food and Drug Administration | 30-10-25 | Medical Device | Quality Management System Information for Certain Premarket Submission Reviews (draft) | Quality | View Page |
| USA | Food and Drug Administration | 30-10-25 | Medical Device | Menstrual Products – Performance Testing and Labeling Recommendations (draft) | Regulatory | View Page |
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