EMA Consultation on the ICH M4Q(R2) Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (step 2b) The European Medicines Agency (EMA) has published for public consultation the ICH M4Q(R2) Guideline on the Common Technical Document for the registration of pharmaceuticals for human use: Quality (step 2b). The consultation closes on 24 October 2025. EMA Consultation on the ICH M4Q(R2) Guideline on the Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality (step 2b)
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
