MHRA Medicines: Updated Guidance on Product Reclassification The MHRA has updated the guidance "Medicines: Reclassify your Product", incorporating the webinar recording of the MHRA reclassification process for medicines in the UK, which took place in November 2024. MHRA Medicines: Updated Guidance on Product Reclassification
MHRA Category 1 List Following Implementation of Windsor Framework MHRA has published the Category 1 list which is an initial list of authorised products on or before 30 November 2024 assigned to Category 1. It will be updated early January 2025 to include all authorised products up to and including 31 December 2024 that fall in Category 1. MHRA Category 1 List Following Implementation of Windsor Framework
MHRA Windsor Framework Guidance Updates MHRA has updated some guidance documents to reflect changes resulting from the Windsor Framework, including the guidance on variations to marketing authorisations (MAs) and on the unfettered access procedure for marketing authorisations approved in Northern Ireland. MHRA Windsor Framework Guidance Updates
EU – COMBINE Program for Clinical Trials and Medical Devices Member State authorities have approved a new strategy for the COMBINE programme. EU – COMBINE Program for Clinical Trials and Medical Devices
MHRA Marketing Authorisations Granted 1 to 14 December MHRA granted 1 OTC licence during 1-14 December 2024. MHRA Marketing Authorisations Granted 1 to 14 December
Draft EU Herbal Monograph on Species pectorales Following adoption by the EMA Committee on Herbal Medicinal Products (HMPC) in November 2024, the draft European Union herbal monograph on Species pectorales has been published for public consultation. Draft EU Herbal Monograph on Species pectorales
CMDh Report – December 2024 Meeting The Co-ordination group for Mutual recognition and Decentralised procedures – human (CMDh) has published the report from the CMDh meeting held on 10-11 December 2024. CMDh Report – December 2024 Meeting
EMA/HMA/EC ePI Pilot Report Published The European Medicines Agency (EMA) / Heads of Medicines Agencies (HMA) / European Commission (EC) Electronic Product Information (ePI) Pilot report has been published. EMA/HMA/EC ePI Pilot Report Published
MHRA Pharmacovigilance Q&A Published MHRA has published a new pharmacovigilance Q&A document to supplement the previously published pharmacovigilance guidance. MHRA Pharmacovigilance Q&A Published
MHRA Marketing Authorisations Granted 15 to 30 November MHRA granted 2 OTC licences during 15-30 November 2024. MHRA Marketing Authorisations Granted 15 to 30 November
New Clinical Trials Legislation Laid in Parliament New Clinical Trials legislation has been laid in Parliament that will address the research sector's need for a more efficient, streamlined and adaptable regulatory framework for clinical trials. New Clinical Trials Legislation Laid in Parliament
MHRA Performance Data for Assessment of New Marketing Authorisations, Variations and Clinical Trial Authorisation The MHRA performance metrics for new marketing authorisation applications, variations, and clinical trial authorisation assessment have been updated. MHRA Performance Data for Assessment of New Marketing Authorisations, Variations and Clinical Trial Authorisation
