MHRA Marketing Authorisations Granted 1 to 14 December 2025 MHRA granted one OTC licence during 1-14 December 2025. MHRA Marketing Authorisations Granted 1 to 14 December 2025
MHRA Safety Roundup – December 2025 MHRA has published the safety roundup for December 2025, which includes a summary of the latest safety advice for medicines and medical device users. This month MHRA also included an update on the workshop hosted by MHRA in early December which focussed on improving Patient Information Leaflets. MHRA Safety Roundup – December 2025
MHRA Seasonal Scientific Advice Update MHRA has updated the guidance on scientific advice to include seasonal request timeframes. MHRA Seasonal Scientific Advice Update
AESGP Guidance on Umbrella Branding for Non‑prescription Medicines The Association of the European Self Care Industry (AESGP) has published guidance on names for non prescription medicinal products. AESGP Guidance on Umbrella Branding for Non‑prescription Medicines
DHSC 10 Year Health Plan Collection DHSC has published a collection related to the 10 Year Health Plan for England. The Government committed to co-developing the plan with members of the public, health and care staff and partner organisations and to do this, Change NHS was launched. The findings of Change NHS are included in the collection. DHSC 10 Year Health Plan Collection
MHRA Performance Data – November 2025 MHRA has published its performance data for November 2025. MHRA Performance Data – November 2025
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
