EU Variation Guideline Revision – Updated EMA and CMDh Guidance The European Medicines Agency (EMA) and Coordination Group for Mutual Recognition and Decentralised Procedures - Human (CMDh) have published updated guidance on the implementation of the new variation framework and its impact on the submission of variations. EU Variation Guideline Revision – Updated EMA and CMDh Guidance
New PAGB Charitable Donations Guidance and Webinar Join us on 9 July to learn more about PAGB's new guidance on charitable donations of human medicines. The session will explore responsible donation practices, highlight PAGB associate member IHP’s global health work in crisis-affected communities, and show how PAGB members can align with ESG and sustainability goals. New PAGB Charitable Donations Guidance and Webinar
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
