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
India CDSCO 19-06-24 Drug Product Chemical Monographs/General Chapters Regulatory View Page
USA Food and Drug Administration 23-05-24 Medical Device Characterization of Metallic Coatings and/or Calcium Phosphate Coatings on Orthopedic Devices (draft for comments) Regulatory View Page
UK Medicines and Healthcare products Regulatory Agency 14-05-24 Drug Apply for a licence to market a medicine in the UK Regulatory View Page
USA Food and Drug Administration 08-05-24 Drug CDER Center for Clinical Trial Innovation (C3TI) Clinical View Page
Malaysia National Pharmaceutical Regulatory Agency 30-04-24 Drug Guideline for application of clinical trial import licence and clinical trial exemption Clinical View Page
Europe European Commission 25-04-24 Medical Device Commission welcomes adoption by European Parliament of measures to improve the availability of in vitro diagnostics Regulatory View Page
Australia Therapeutic Goods Administration 24-04-24 Drug Nitrosamine impurities acceptable intakes update Regulatory View Page
Europe European Commission 22-04-24 Medical Device Charting the path forward: Joint stakeholder statement on the implementation of the EHDS Regulatory View Page
The Philippines Philippines FDA 16-04-24 Drug Prescribing the Guidelines on Good Manufacturing Practice (GMP) for Drug Manufacturers Repealing AO No. 2013-0022 (draft for comments) Regulatory View Page
The Philippines Philippines FDA 15-04-24 Drug Clarification on the requirements for change of Qualified Person initially registered in a licensed drug establishment Regulatory View Page
International The Eurasian Economic Union 12-04-24 Drug Updates in uniform Rules for conducting bioequivalence studies of medicinal products Clinical View Page
International The Eurasian Economic Union 12-04-24 Drug Updates in the unified Rules for conducting pharmaceutical inspections of pharmacovigilance systems of drug manufacturers Pharmacovigilance View Page
New Zealand New Zealand Medicines and Medical Devices Safety 11-04-24 Medical Device Outcome of the consultation on standards for contraceptive devices in New Zealand Regulatory View Page
Europe European Directorate for the Quality of Medicines and Healthcare 09-04-24 Drug JP and Ph. Eur. launch a bilateral prospective harmonisation project for active substance and medicinal product monographs Regulatory View Page
Japan Pharmaceuticals and Medical Devices Agency 08-04-24 Drug New drug review with electronic data Regulatory View Page
Malaysia National Pharmaceutical Regulatory Agency 08-04-24 Drug Malaysian guideline for Bioequivalence inspection 2nd edition (draft for comments) Clinical View Page
Brazil Brazilian Health Regulatory Agency 08-04-24 Medical Device ANVSIA will use assessment from foreign authorities to register medical devices Regulatory View Page
UK Medicines and Healthcare products Regulatory Agency 05-04-24 Drug Disapplication of Falsified Medicines Directive Safety Features: Requirements for Parallel Imports Regulatory View Page
UK Medicines and Healthcare products Regulatory Agency 05-04-24 Drug UK Parallel Import Licences Following Agreement of the Windsor Framework Regulatory View Page
Europe European Directorate for the Quality of Medicines and Healthcare 04-04-24 Drug As a CEP applicant, you want to improve the quality of your dossier? The revised EDQM guideline “content of the dossier” and other key documents will be useful tools Regulatory View Page
India Central Drugs Standard Control Organisation 03-04-24 Medical Device Strengthening of private medical devices testing laboratory in India Regulatory View Page
Ireland Health Products Regulatory Authority 03-04-24 Drug Submitting a Request for a New National Application Procedure for a Human Medicinal Product Regulatory View Page
Australia Therapeutic Goods Administration 02-04-24 Drug Updated guidelines for Assessed listed medicines Regulatory View Page
International World Health Organization 01-04-24 Drug WHO Good Manufacturing Practices considerations for the prevention and control of nitrosamine contamination in pharmaceutical products (draft for comments) Regulatory View Page
The Philippines Philippines FDA 01-04-24 Drug Guidelines on the Classification of Deficiencies Observed During Inspection of Drug Distributors, Drugstores, Hospital Pharmacies and Retail Outlet for Non-Prescription Drugs (RONPD) (draft for comments) Regulatory View Page

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