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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
Europe European Medicines Agency 01-11-24 Drug Transitional trials from EudraCT to CTIS Clinical View Page
USA Food and Drug Administration 31-10-24 Drug Product-Specific Guidance’s; Revised Draft Guidance’s for Industry Clinical View Page
Europe European Commission 30-10-24 Drug Q&A Obligation to inform in case of interruption or discontinuation of supply Regulatory View Page
Europe European Commission 29-10-24 Medical Device MDCG 2024-13 – Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices – October 2024 Regulatory View Page
Europe European Commission 29-10-24 Medical Device MDCG 2022-5 rev.1 – Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices – October 2024 Regulatory View Page
Europe European Commission 24-10-24 Medical Device Team-NB views on implementation of MDR/IVDR Regulations Regulatory View Page
Europe European Food Safety Authority 24-10-24 Food & Food Supplement Safety of an extension of use of oil from Schizochytrium limacinum (strain FCC‐3204) as a novel food pursuant to Regulation (EU) 2015/2283 Novel Food View Page
UK Medicines and Healthcare products Regulatory Agency 22-10-24 Medical Device Statutory Instrument laid in Parliament sets out first steps in delivering Medical Device Regulatory Reform and strengthening patient safety Safety View Page
USA Food and Drug Administration 21-10-24 Drug Classifying Resubmissions of Original NDAs, BLAs, and Efficacy Supplements in Response to Complete Response Letters Regulatory View Page
USA Food and Drug Administration 18-10-24 Drug Core Patient-Reported Outcomes in Cancer Clinical Trials; Guidance for Industry Clinical View Page
India Central Drugs Standard Control Organisation 18-10-24 Drug Joint Working Group Meeting Held to Strengthen Pharmacopoeial Cooperation Regulatory View Page
USA Food and Drug Administration 15-10-24 Medical Device Endosseous Dental Implants and Endosseous Dental Implant Abutments – Performance Criteria for Safety and Performance Based Pathway Regulatory View Page
Switzerland The Swiss Agency for Therapeutic Products 15-10-24 Drug Changes to the guidance documents Fast-track authorisation procedure and Temporary authorisation for human medicinal products Regulatory View Page
India Central Drugs Standard Control Organisation 11-10-24 Biologics National Regulatory Authority of India meets WHO international standards for vaccine regulations Regulatory View Page
Australia Therapeutic Goods Administration 11-10-24 Medical Device Medical devices affected by 3G network closure in October 2024 Regulatory View Page
New Zealand New Zealand Medicines and Medical Devices Safety 08-10-24 Drug Classification of Medicines – Paracetamol Regulatory View Page
New Zealand New Zealand Medicines and Medical Devices Safety 08-10-24 Drug Classification of Medicines – Naproxen Regulatory View Page
Europe European Commission 07-10-24 Medical Device MDCG 2024-12 – Guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams Regulatory View Page
Europe European Medicines Agency 07-10-24 Drug Guideline on clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease of the lower extremities Clinical View Page
India Central Drugs Standard Control Organisation 03-10-24 Medical Device Central Drugs Standard Control Organization under Ministry of Health & Family Welfare becomes Affiliate Member of the International Medical Device Regulators Forum Regulatory View Page
Europe European Food Safety Authority 03-10-24 Food & Food Supplement Administrative guidance for the preparation of novel food applications in the context of Article 10 of Regulation (EU) 2015/2283 Novel Food View Page
Europe European Medicines Agency 02-10-24 Drug Improving efficiency of approval process for new medicines in the EU Regulatory View Page
USA Food and Drug Administration 01-10-24 Drug Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations Questions and Answers Regulatory View Page
Europe European Commission 01-10-24 Medical Device Transition to the Implementation of Class D oversight by EURLs Regulatory View Page
Europe European Commission 01-10-24 Medical Device MDCG 2024-11 Guidance on qualification of in vitro diagnostic medical devices Regulatory View Page

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