MHRA Publishes Business Plan for 2025/6 The Medicines and Healthcare products Regulatory Agency (MHRA) has published its Business Plan for 2025/26, reaffirming its commitment to keeping patients safe and enabling access to high quality and effective medical products through innovation across the UK. MHRA Publishes Business Plan for 2025/6
CMDh June 2025 Meeting – Report The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 17-19 June 2025. CMDh June 2025 Meeting – Report
PAGB Charitable Donations Guidance and Webinar Join PAGB and International Health Partners (IHP) on Wednesday 9 July for a webinar introducing new guidance on charitable donations of human medicines. The session will explore responsible donation practices, highlight IHP’s global health work in crisis-affected communities, and show how PAGB members can align with ESG and sustainability goals. PAGB Charitable Donations Guidance and Webinar
MHRA Performance Data – May 2025 MHRA has published its performance data for May 2025. MHRA Performance Data – May 2025
MHRA – Stricter Validation of eCTD Submissions To improve the quality of submissions, the MHRA is now requiring stricter adherence to eCTD specifications. MHRA – Stricter Validation of eCTD Submissions
MHRA – Scientific Advice Request – List of Questions MHRA has updated their guidance on getting scientific advice to highlight that they will not be able to process receipt of requests until they have received a complete list of questions to be asked. MHRA – Scientific Advice Request – List of Questions
MHRA Safety Roundup May 2025 MHRA's safety bulletin, the MHRA Safety Roundup, for May 2025 has been published. This includes a summary of all safety alerts (including Drug Safety Updates) published during the month for medicines and medical devices. MHRA Safety Roundup May 2025
EU – COMBINE Program for Clinical Trials and Medical Devices – Pilot Launch As part of the COMBINE programme, Member State authorities have launched a pilot to test a new, more efficient way of approving combined studies. EU – COMBINE Program for Clinical Trials and Medical Devices – Pilot Launch
EMA Management Board – June 2025 – Meeting highlights The highlights of the European Medicines Agency (EMA) Management Board June 2025 meeting have been published. EMA Management Board – June 2025 – Meeting highlights
MHRA Publishes Marketing Authorisations Granted 15 May to 31 May 2025 MHRA granted 5 OTC licences during 15-31 May 2025. MHRA Publishes Marketing Authorisations Granted 15 May to 31 May 2025
MHRA – Updated Guidance on Supplying Authorised Medicines to Northern Ireland MHRA has updated the guidance on supplying authorised medicines to Northern Ireland. An overview has been added and sections 2, 3 and 4 have been updated to reflect the implementation of the Windsor Framework on 1 January 2025. MHRA – Updated Guidance on Supplying Authorised Medicines to Northern Ireland
MHRA RegulatoryConnect Webinar Recording MHRA has published the recording of the RegulatoryConnect webinar which took place on 22 May 2025. MHRA RegulatoryConnect Webinar Recording
