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
Europe European Medicines Agency 27-06-24 Medical Device MDCG 2024-1-5 – Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence (June 2024) Safety View Page
Australia Therapeutic Goods Administration 26-06-24 Medical Device Medical device regulation changes Regulatory View Page
Europe European Directorate for the Quality of Medicines and Healthcare 26-06-24 Drug New general chapter on Extractable elements in plastic materials for pharmaceutical use (2.4.35) adopted Regulatory View Page
Switzerland The Swiss Agency for Therapeutic Products 26-06-24 Medical Device Go-live for the swissdamed Actors module Regulatory View Page
Europe European Commission 21-06-24 Drug Joint clinical assessment of medicinal products: Submission of early information by health technology developers Clinical View Page
India Central Drugs Standard Control Organisation 19-06-24 Drug Chemical Monographs/General Chapters Regulatory View Page
Europe European Medicines Agency 18-06-24 Drug Faster access to clinical trial information in Europe Clinical View Page
USA Food and Drug Administration 18-06-24 Drug Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases Regulatory View Page
Australia Therapeutic Goods Administration 18-06-24 Biologics Update on the glucagon-like peptide-1 receptor agonists (GLP-1 RAs) pharmacy compounding changes Safety View Page
Hong Kong Department of Health – Hong Kong 17-06-24 Drug Regulation of medical gases as pharmaceutical products Regulatory View Page
USA Food and Drug Administration 14-06-24 Drug Amending Over-the-Counter Monograph M013: Internal Analgesic, Antipyretic, and Antirheumatic Drug Products for Over-the-Counter Human Use Regulatory View Page
Europe European Commission 13-06-24 Drug Health Technology Assessment: two new guidance documents published (joint clinical assessments and reporting requirements) Clinical View Page
USA Food and Drug Administration 12-06-24 Drug Waivers and Exemptions Beyond the Stabilization Period Regulatory View Page
Europe European Medicines Agency 10-06-24 Drug Two new advice pilots to improve clinical trials in Europe Clinical View Page
Europe European Medicines Agency 10-06-24 Biologics Tailored scientific advice to support step-by-step development of new biosimilars Regulatory View Page
Australia Therapeutic Goods Administration 07-06-24 Medical Device Proactive monitoring of highest-risk medical device clinical trials Clinical View Page
Switzerland The Swiss Agency for Therapeutic Products 07-06-24 Drug New implementing regulations apply as of 1 November 2024 Clinical View Page
Malaysia Medical Device Authority 05-06-24 Medical Device Announcement on the implementation of the use of electronic establishment license certificate beginning, June 5 2024 Regulatory View Page
Hong Kong Department of Health – Hong Kong 05-06-24 Drug DH establishes Preparatory Office for Hong Kong Centre for Medical Products Regulation Regulatory View Page
USA Food and Drug Administration 04-06-24 Medical Device 510(k) Third Party Performance Metrics and Accreditation Status Regulatory View Page
USA Food and Drug Administration 03-06-24 Medical Device SOPP 8795: Posting and announcement of Premarket Approval Application and Humanitarian Device Exemption Approvals and Denials Regulatory View Page
USA Food and Drug Administration 01-06-24 Biologics Standardized Format for Electronic Submission for Marketing Applications Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for Center for Biologics Evaluation and Research Submissions (draft guidance) Regulatory View Page
USA Food and Drug Administration 01-06-24 Biologics Processes and practices applicable to Bioresearch Monitoring Inspections (draft guidance) Regulatory View Page
Switzerland The Swiss Agency for Therapeutic Products 01-06-24 Drug Changes to the guidance document time limits for authorization applications Regulatory View Page
Switzerland The Swiss Agency for Therapeutic Products 01-06-24 Drug Changes to the guidance document meetings for applicants for authorization procedures Regulatory View Page

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