MHRA Fees – Wholesale Distribution Authorisation Fees Update The MHRA has published a correction to their statutory fees for wholesale distribution authorisations fees. MHRA Fees – Wholesale Distribution Authorisation Fees Update
MHRA – Clinical Investigations for Medical Devices – Guidance Update MHRA has updated their guidance on Clinical Investigations for Medical Devices. MHRA – Clinical Investigations for Medical Devices – Guidance Update
MHRA Welcomes Chief Medical and Scientific Officer The MHRA has welcomed Professor Jacob George as he started as Chief Medical and Scientific Officer (CMSO) on 5 January. MHRA Welcomes Chief Medical and Scientific Officer
Government Response: Disclosure of Industry Payments to Healthcare Sector The Department of Health and Social Care (DHSC) has published the Government response to the public consultation which ran in 2023 to seek the views of individuals and organisations in relation to disclosure of industry payments to the healthcare sector. Government Response: Disclosure of Industry Payments to Healthcare Sector
EMA Consultation – ICH E22 Guideline on General Considerations for Patient Preference Studies The European Medicines Agency (EMA) has published for public consultation the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E22 Guideline on general considerations for patient preference studies (PPS). The deadline for comments is 12 April 2026. EMA Consultation – ICH E22 Guideline on General Considerations for Patient Preference Studies
EMA Management Board – December 2025 The highlights of the European Medicines Agency (EMA) Management Board December 2025 meeting have been published. EMA Management Board – December 2025
Independent Review of Windsor Framework Published The UK Government has published the Independent Review of the Windsor Framework, assessing its operation since implementation. The review examines economic, social, and regulatory impacts, with implications for post-Brexit divergence and compliance requirements affecting UK businesses. Independent Review of Windsor Framework Published
MHRA Call for Evidence on AI Regulation in Healthcare MHRA has launched a Call for Evidence to inform the National Commission on the Regulation of AI in Healthcare. This initiative aims to shape a framework that safeguards patients while enabling responsible innovation and growth across the HealthTech sector and NHS. Responses are invited from all stakeholders, including patients, professionals, and industry innovators, by 2 February 2026. MHRA Call for Evidence on AI Regulation in Healthcare
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
