CMDh December 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the meeting held on 9 - 11 December 2025. CMDh December 2025 Meeting – Report
EU General Pharmaceutical Legislation Revision Provisional Agreement The European Parliament and Council have reached a provisional agreement on the revision of the General Pharmaceutical Legislation. EU General Pharmaceutical Legislation Revision Provisional Agreement
EU – Biotech Act – Legislative Proposal The European Commission published a proposal for a European Biotech Act, aiming to establish a framework of measures for strengthening Union’s biotechnology and biomanufacturing sectors particularly in the area of health. EU – Biotech Act – Legislative Proposal
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
