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
10-Year Health Plan – Recording of Webinar on How MHRA and NICE Will Bring Medicines to Patients Months Sooner The recording of the webinar on how the collaboration between MHRA and NICE will bring medicines to patients sooner is now available. 10-Year Health Plan – Recording of Webinar on How MHRA and NICE Will Bring Medicines to Patients Months Sooner
MHRA – Borderline Products Advice Form Updated MHRA has updated the medicines borderline advice form in their guidance 'borderline products: how to tell if your product is a medicine'. MHRA – Borderline Products Advice Form Updated
MHRA – Apply for a Variation to your Marketing Authorisation Guidance Updated MHRA has updated their guidance - 'Medicines: apply for a variation to your marketing authorisation'. MHRA – Apply for a Variation to your Marketing Authorisation Guidance Updated
