Get the most out of your PAGB membership – join our next session! Join PAGB's upcoming Making the most of your membership session on 15 October to get an overview of our services, support and how best to access each service. Get the most out of your PAGB membership – join our next session!
Updated EU Variations Guidelines Published The European Commission has published updated guidelines on marketing authorisation variations, aligning with the 2024 amendment to the Variations Regulation. These new rules will take effect from 15 January 2026. Updated EU Variations Guidelines Published
MHRA Marketing Authorisations Granted 1 to 14 September 2025 MHRA granted 3 OTC licences during 1 - 14 September 2025. MHRA Marketing Authorisations Granted 1 to 14 September 2025
MHRA Performance Data – August 2025 MHRA has published its performance data for August 2025. MHRA Performance Data – August 2025
10-Year Health Plan – Free Webinar on How MHRA and NICE Will Bring Medicines to Patients Months Sooner Free webinar about how the collaboration between MHRA and NICE will bring medicines to patients sooner. 10-Year Health Plan – Free Webinar on How MHRA and NICE Will Bring Medicines to Patients Months Sooner
MHRA & Department for Education Embed Medicine Safety Into School Curriculum The importance of medicine safety and how to report side effects of medicines via the Yellow Card scheme is now part of the statutory guidance for schools in England. MHRA & Department for Education Embed Medicine Safety Into School Curriculum
MHRA Blog – Looking to Our Future: Reflections on the Strategic Choices Ahead for the MHRA MHRA is publishing a series of blogs on the challenges and opportunities ahead. In the first instalment, Chief Executive Lawrence Tallon reflects on the changing healthcare landscape, the regulator’s role, and the priorities shaping the agency’s future direction. MHRA Blog – Looking to Our Future: Reflections on the Strategic Choices Ahead for the MHRA
DHSC Public Appointments The Department of Health and Social Care (DHSC) has published information about non-executive appointments to DHSC's public bodies and committees in September 2025. DHSC Public Appointments
MHRA – Additional Information for Change of Ownership MHRA has added additional information on change of ownership in the guidance 'apply for manufacturer or wholesaler of medicines licences' which contains information on how to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines. MHRA – Additional Information for Change of Ownership
European Commission Consultation – GMP Guidelines Chapter 1: Pharmaceutical Quality System The European Commission has launched a public consultation on a revised Good Manufacturing Practice (GMP) Chapter 1: Pharmaceutical Quality System. The deadline is 3 December 2025. European Commission Consultation – GMP Guidelines Chapter 1: Pharmaceutical Quality System
MHRA – Parallel Import Variation Tell-and-Do (TaD) Cover Sheet MHRA has updated the 'Parallel Import Variation Tell-and-Do (TaD) Cover Sheet' in the guidance 'medicines: apply for a parallel import licence'. MHRA – Parallel Import Variation Tell-and-Do (TaD) Cover Sheet
EMA ICH Consultation – Q3E Draft Guideline for Extractables and Leachables & Supporting Documentation The European Medicines Agency (EMA) has published for public consultation the draft International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3E Guideline for extractables and leachables and ICH Q3E Guideline for extractables and leachables - supporting documentation: class 3 leachable monographs. EMA ICH Consultation – Q3E Draft Guideline for Extractables and Leachables & Supporting Documentation
