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
Brazil Brazilian Health Regulatory Agency 29-11-24 Drug Anvisa approves new framework for clinical research rules in the country Clinical View Page
Malaysia Medical Device Authority 26-11-24 Medical Device Control of obsolete and discontinued medical device in healthcare or related facilities Regulatory View Page
USA Food and Drug Administration 26-11-24 Medical Device Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices Regulatory View Page
Europe European Commission 26-11-24 Medical Device MDCG 2024-14 – Guidance on the implementation of the Master UDI-DI solution for contact lenses Labeling View Page
Australia Therapeutic Goods Administration 26-11-24 Drug Temporary labelling exemptions for paracetamol Labeling View Page
USA Food and Drug Administration 22-11-24 Medical Device Orthopedic Non-Spinal Bone Plates, Screws, and Washers – Premarket Notification (510(k)) Submissions Regulatory View Page
USA Food and Drug Administration 22-11-24 Medical Device Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway Safety View Page
The Philippines Philippines FDA 22-11-24 Drug Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No. 2020-0017 Regulatory View Page
USA Food and Drug Administration 21-11-24 Medical Device 510(k) Third Party Review Program and Third-Party Emergency Use Authorization (EUA) Review Regulatory View Page
Australia Therapeutic Goods Administration 21-11-24 Medical Device Adoption of International Scientific Guidelines in Australia R01-2024 Regulatory View Page
Europe European Commission 21-11-24 Medical Device Gradual roll out of EUDAMED – Q&As on practical aspects related to the implementation of Regulation (EU) 2024/1860 Regulatory View Page
Australia Therapeutic Goods Administration 20-11-24 Drug Product Information safety updates – November 2024 Safety View Page
Australia Therapeutic Goods Administration 20-11-24 Drug Mandatory requirements for an effective over-the-counter medicines application (updated) Regulatory View Page
Australia Therapeutic Goods Administration 19-11-24 Drug Promethazine hydrochloride (Phenergan) not to be used in children under 6 Safety View Page
Malaysia National Pharmaceutical Regulatory Agency 15-11-24 Medical Device Announcement to Product Registration Holders (PRHs): Pilot Project for Post-Approval Changes (Variation) Using Reliance Regulatory View Page
Austria The Austrian Agency for Health and Food Safety 15-11-24 Food & Food Supplement Saccharin: No health risk Safety View Page
Europe European Medicines Agency 15-11-24 Drug EMA encourages companies to submit type I variations for 2024 by end November 2024 Regulatory View Page
UK Medicines and Healthcare products Regulatory Agency 14-11-24 Medical Device Medical Devices Regulations: Routes to market and in vitro diagnostic devices Regulatory View Page
The Philippines Philippines FDA 13-11-24 Drug Reiteration of submission of batch notification representative sample/s and required documents/s (post submission) Regulatory View Page
Europe European Commission 11-11-24 Medical Device Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 under Regulation (EU) 2017/746 Pharmacovigilance View Page
Australia Therapeutic Goods Administration 11-11-24 Drug Medicine shortages and discontinuations: Proposed changes to reporting requirements Regulatory View Page
Spain The Spanish Agency of Medicines and Medical Devices 11-11-24 Drug The AEMPS incorporates an automatic Apostille service in CPP applications for finished medicines for human use registered in Spain Regulatory View Page
India Central Drugs Standard Control Organisation 08-11-24 Medical Device Operational Guidelines for the Scheme “Strengthening of Medical Device Industry” Central Sector Scheme under Department of Pharmaceuticals Regulatory View Page
Brazil Brazilian Health Regulatory Agency 08-11-24 Drug Anvisa adopts artificial intelligence strategy in drug analysis Regulatory View Page
Costa Rica Ministry of Health 08-11-24 Drug Costa Rica and the FDA strengthen regulatory processes in health for greater efficiency and productivity Regulatory View Page

Let’s Build a Healthier & Safer World, Together

Connect with ClinChoice to discover how we can support the
development and commercialization of your drug or device.

Get In Touch