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 |
---|---|---|---|---|---|---|
UK | Medicines and Healthcare products Regulatory Agency | 10-02-25 | Drug | MHRA Real-World Evidence Scientific Dialogue Programme | Real-World Evidence | View Page |
UK | Medicines and Healthcare products Regulatory Agency | 31-01-25 | Drug | Medicines: get scientific advice from MHRA | Regulatory | View Page |
International | International Medical Device Regulators Forum | 29-01-25 | Medical Device | Good Machine Learning Practice for Medical Device Development: Guiding Principles | Regulatory | View Page |
International | International Medical Device Regulators Forum | 27-01-25 | Medical Device | Characterization Considerations for Medical Device Software and SoftwareSpecific Risk | Regulatory | View Page |
Europe | European Medicines Agency | 27-01-25 | Drug | ICH E6 (R3) Guideline for good clinical practice (GCP) | Clinical | View Page |
Europe | European Food Safety Authority | 27-01-25 | Food & Food Supplement | Safety of a change of specifications of phytosterols/phytostanols as a novel food pursuant to Regulation (EU) 2015/2283 | Novel Food | View Page |
Brazil | Brazilian Health Regulatory Agency | 24-01-25 | Drug | Anvisa’s User Service Charter includes 14 new services | Regulatory | View Page |
Europe | European Food Safety Authority | 23-01-25 | Food & Food Supplement | Administrative guidance for the preparation of applications on new nutrient sources | Regulatory | View Page |
Malaysia | Medical Device Authority | 22-01-25 | Medical Device | Importation of medical device for personal use | Regulatory | View Page |
Australia – New Zealand | Food Standards Australia New Zealand | 21-01-25 | Food & Food Supplement | Food Standards Work Plan –proposed standards development and variations to standards for applications and proposals | Regulatory | View Page |
USA | Food and Drug Administration | 17-01-25 | Drug | Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications; Establishment of a Public Docket; Request for Comments | Regulatory | View Page |
Switzerland | The Swiss Agency for Therapeutic Products | 16-01-25 | Drug | Legal mandate: surveillance of reporting and advertising for medicinal products | Pharmacovigilance | View Page |
UK | Medicines and Healthcare products Regulatory Agency | 15-01-25 | Medical Device | Medical devices: post-market surveillance | Pharmacovigilance | View Page |
Australia | Therapeutic Goods Administration | 15-01-25 | Drug | Consent relating to listed medicines that contain whole live microorganisms as an active ingredient | Regulatory | View Page |
UK | Medicines and Healthcare products Regulatory Agency | 15-01-25 | Medical Device | MHRA guidance on new Medical Devices Post-Market Surveillance requirements | Pharmacovigilance | View Page |
Europe | European Food Safety Authority | 15-01-25 | Food & Food Supplement | Safety of mineral salt containing potassium and magnesium as a novel food pursuant to Regulation (EU) 2015/2283 | Novel Food | View Page |
Europe | European Medicines Agency | 14-01-25 | Drug | Revised rules on handling of competing interests published | Regulatory | View Page |
USA | Food and Drug Administration | 13-01-25 | Medical Device | Premarket Approval Application and Humanitarian Device Exemption Modular Review | Regulatory | View Page |
USA | Food and Drug Administration | 07-01-25 | Medical Device | Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act | Regulatory | View Page |
USA | Food and Drug Administration | 07-01-25 | Medical Device | Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (draft guidance) | Regulatory | View Page |
USA | Food and Drug Administration | 07-01-25 | Medical Device | Pulse Oximeters for Medical Purposes – Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations (draft guidance) | Clinical | View Page |
UK | Medicines and Healthcare products Regulatory Agency | 07-01-25 | Drug | Supplementary information for international regulators: export of UK medicines and the new Windsor Framework (Northern Ireland) labelling requirements | Labeling | View Page |
China | National Medical Products Administration | 06-01-25 | Drug | China deepens comprehensive reform to strengthen drug, medical device regulation | Regulatory | View Page |
India | Central Drugs Standard Control Organisation | 06-01-25 | Medical Device | Updating existing risk-based classification | Regulatory | View Page |
International | International Council for Harmonisation Of Technical Requirements For Pharmaceuticals For Human Use | 06-01-25 | Drug | Guideline For Good Clinical Practice E6(R3) | Clinical | View Page |
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