One Substance One Assessment – Publication of Regulations The One Substance, One Assessment (OSOA) regulations have been published in the EU Official Journal. One Substance One Assessment – Publication of Regulations
EMA – Updated Q&A on Drug Device Combination Products (Dec 2025) The European Medicines Agency (EMA) has updated its Questions and Answers on Drug Device Combination Products (6th revision). EMA – Updated Q&A on Drug Device Combination Products (Dec 2025)
EU Union List of Critical Medicines Published The EU has published a new version of the Union list of critical medicines and Q&A document. EU Union List of Critical Medicines Published
EMA Webinar on New Variation Guideline EMA, the European Medicines Agency, is hosting a webinar for Marketing Authorisation Holders on the new variation guideline (human) on 13 Jan 2026. EMA Webinar on New Variation Guideline
EMA – Work Plans The European Medicines Agency (EMA) has published 3-year work plans for the non-clinical domain, joint CHMP/CVMP Quality Working Party and Methodology Working Party. EMA – Work Plans
MHRA and the Department of Health Northern Ireland MHRA and Northern Ireland partners have announced a strengthened programme of collaboration designed to support innovation, enhance patient safety and ensure people in Northern Ireland continue to benefit from world-class regulation of medicines and medical technologies. MHRA and the Department of Health Northern Ireland
MHRA Marketing Authorisations Granted 15 to 30 November 2025 MHRA granted five OTC licences during 15-30 November 2025. MHRA Marketing Authorisations Granted 15 to 30 November 2025
MHRA Top Tips for the Festive Period MHRA has shared five top tips to help people to stay well through the festive season and beyond. MHRA Top Tips for the Festive Period
MHRA – A Guide to What is a Medicinal Product – Guidance Update MHRA has updated their Guide to What is a Medicinal Product (MHRA Guidance Note 8). MHRA – A Guide to What is a Medicinal Product – Guidance Update
UK-EU Trade Partnership Committee – 12 December 2024 Meeting Minutes The minutes of the 4th meeting of the Trade Partnership Committee under the Agreement between the European Union (EU) and the United Kingdom (UK) for Trade and Cooperation (TCA), which took place on 12 December 2024, have been published. UK-EU Trade Partnership Committee – 12 December 2024 Meeting Minutes
EMA – Updated Q&A on Drug Device Combination Products The European Medicines Agency (EMA) has updated its Questions and Answers on Drug Device Combination Products. EMA – Updated Q&A on Drug Device Combination Products
Persistent Organic Pollutants – Stockholm Convention Updates, UK & EU Implementation Timelines The Department for Environment, Food and Rural Affairs (Defra) has shared information and updates relating to the implementation of decisions recently made by Conference of the Parties (COP) to the Stockholm Convention Persistent Organic Pollutants – Stockholm Convention Updates, UK & EU Implementation Timelines
