MHRA Guest Blog: Patient Safety Commissioner Calls for Patient-Led Safety Strategy England’s Patient Safety Commissioner, Professor Henrietta Hughes, calls for MHRA’s future strategy to place patient safety at the heart of regulatory innovation. MHRA Guest Blog: Patient Safety Commissioner Calls for Patient-Led Safety Strategy
EMA Launches Webpage for Combination Products Group The European Medicines Agency (EMA) has launched a dedicated webpage for the Combination Products Operational Group (COMBO). EMA Launches Webpage for Combination Products Group
MHRA Marketing Authorisations Granted 15 to 31 October 2025 MHRA granted 3 OTC licences during 15 - 31 October 2025. MHRA Marketing Authorisations Granted 15 to 31 October 2025
EU Medicines – Revised Q&A on the Impact of EU/US Mutual Recognition Agreement on GMP Inspections, Marketing Authorisation Applications Two Q&A, related to the impact of EU/US Mutual Recognition Agreement, one on GMP inspections and the other on marketing authorisation applications, have been revised. EU Medicines – Revised Q&A on the Impact of EU/US Mutual Recognition Agreement on GMP Inspections, Marketing Authorisation Applications
MHRA – First Chief Medical and Scientific Officer Appointed Professor Jacob George has been appointed as the first Chief Medical and Scientific Officer for MHRA. MHRA – First Chief Medical and Scientific Officer Appointed
AESGP Webinar – Changing Landscape on ERA for Medicinal Products AESGP - the European Self-Care Industry Association - is organising a webinar on the changing landscape on Environmental Risk Assessment (ERA) for medicinal products for human use. The webinar will take place on 26 November between 11am - 1pm (GMT). AESGP Webinar – Changing Landscape on ERA for Medicinal Products
UK Regulator Dashboard Published The Department for Business and Trade has published the UK Regulator Dashboard containing information and KPIs from 16 UK regulators, published as part of the government’s Regulatory Action Plan. UK Regulator Dashboard Published
MHRA Safety Roundup October 2025 MHRA's safety bulletin, the MHRA Safety Roundup, for October 2025 has been published. MHRA Safety Roundup October 2025
Herbal Medicines Granted a Traditional Herbal Registration MHRA has updated the list of herbal medicines currently holding a traditional herbal registration (THR) granted by the MHRA. Herbal Medicines Granted a Traditional Herbal Registration
CMDh July 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from their meeting held on 14-15 October 2025. CMDh July 2025 Meeting – Report
ICH M14 Guideline Published – Pharmacoepidemiological Studies Using Real-world Data for Safety Assessment of Medicines The European Medicines Agency (EMA) has published the ICH M14 guideline on general principles on planning, designing, analysing and reporting of pharmacoepidemiological studies that utilize real-world data for safety assessment of medicines. ICH M14 Guideline Published – Pharmacoepidemiological Studies Using Real-world Data for Safety Assessment of Medicines
MHRA Performance Data – September 2025 MHRA has published its performance data for September 2025. MHRA Performance Data – September 2025
