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 |
---|---|---|---|---|---|---|
USA | Food and Drug Administration | 31-07-25 | Drug | FDA Requires Major Changes to Opioid Pain Medication Labeling to Emphasize Risks | Labeling | View Page |
Singapore | Health Sciences Authority | 30-07-25 | Drug | Regulatory Updates for Therapeutic Product Registration (effective 30 July 25) | Regulatory | View Page |
Hong Kong | Department of Health Hong Kong | 30-07-25 | Drug | Co-operation Arrangement to deepen exchange and co-operation in regulation of drugs and medical devices | Regulatory | View Page |
Switzerland | The Swiss Agency for Therapeutic Products | 23-07-25 | Drug | Adoption of ICH GCP Guideline E6(R3) | Clinical | View Page |
UK | Medicines and Healthcare products Regulatory Agency | 22-07-25 | Medical Device | Response to Assimilated EU Law consultation proposal | Regulatory | View Page |
UK | Medicines and Healthcare products Regulatory Agency | 22-07-25 | Medical Device | MHRA announces proposals to improve access to world’s best medical devices for patients and to boost economic growth in Britain’s med tech sector | Regulatory | View Page |
Europe | European Medicines Agency | 22-07-25 | Drug | Guideline on good pharmacovigilance practices (GVP) Module VI Addendum II – Masking of personal data in individual case safety reports submitted to EudraVigilance | Pharmacovigilance | View Page |
Mexico | COFEPRIS | 21-07-25 | Drug | Mexico advances in modernizing its health regulatory framework: COFEPRIS and ATDT | Regulatory | View Page |
Singapore | Health Sciences Authority | 21-07-25 | Medical Device | Update for Guidelines on Risk Classification of SaMD and Qualification of Clinical Decision Support Software (CDSS) | Clinical | View Page |
USA | Food and Drug Administration | 18-07-25 | Drug | Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products Guidance for Industry | Regulatory | View Page |
Europe | European Directorate for the Quality of Medicines and Healthcare | 18-07-25 | Drug | EPC adopts three revised texts related to pharmaceutical waters – a major step towards global quality standards for sterilized water for injections | Regulatory | View Page |
Japan | Pharmaceuticals and Medical Devices Agency | 18-07-25 | Drug | Joint Statement on Cooperation between Japan and the Republic of Korea on Medical Products Regulations | Regulatory | View Page |
India | Central Drugs Standard Control Organisation | 17-07-25 | Drug | Guidance document for issuance of no objection certificate for manufacture of unapproved/approved new drugs for export purpose | Regulatory | View Page |
USA | Food and Drug Administration | 17-07-25 | Medical Device | Regulatory relief for certain stationary sources to promote American security with respect to sterile medical equipment | Regulatory | View Page |
Europe | European Medicines Agency | 16-07-25 | Drug | CTIS Simplification Task Force | Clinical | View Page |
Europe | European Medicines Agency | 15-07-25 | Drug | Clinical pharmacology and pharmacokinetics: questions and answers | Clinical | View Page |
Europe | European Directorate for the Quality of Medicines and Healthcare | 15-07-25 | Drug | EPC successfully concludes pilot phase on monoclonal antibodies, setting the stage for future standardization in this field | Clinical | View Page |
India | Central Drugs Standard Control Organisation | 15-07-25 | Drug | Grant of WHO GMP COPP through portal | Regulatory | View Page |
India | Central Drugs Standard Control Organisation | 12-07-25 | Drug | Issues related to safety of Ranitidine drug due to presence of NDMA impurity | Regulatory | View Page |
Japan | Pharmaceuticals and Medical Devices Agency | 11-07-25 | Medical Device | Pharmacopeial Discussion Group announces outcome of 2025 expansion round | Regulatory | View Page |
Europe | European Commission | 10-07-25 | Medical Device | Timelines of implementation of ‘Master UDI-DI’ to contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles | Regulatory | View Page |
India | Central Drugs Standard Control Organisation | 09-07-25 | Drug | Clinical trial applications for cell and gene therapy products through SUGAM portal | Clinical | View Page |
Europe | European Commission | 08-07-25 | Medical Device | Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of medical devices | Regulatory | View Page |
Europe | European Medicines Agency | 08-07-25 | Drug | Nitrosamine impurities in human medicines | Regulatory | View Page |
International | PIC/S | 07-07-25 | Drug | The African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD) becomes a new PIC/S Associated Partner Organisation | Regulatory | View Page |
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