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
Consultation on EU Medicines Regulatory Network Data Strategy The European Medicines Regulatory Network (EMRN) has released its data strategy for consultation. Consultation on EU Medicines Regulatory Network Data Strategy
Data Quality Framework for EU Medicines Regulation: Application to Real-World-Data The European Medicines Agency (EMA) has released its Data Quality Framework for EU medicines regulation: application to Real-World-Data for consultation. The document aims to provides guidance on how to assess quality of real-world data in the evaluation of medicines and to enhance the use of real-world data in regulatory decisions. Data Quality Framework for EU Medicines Regulation: Application to Real-World-Data
Recording Available: MHRA Webinar on Managing Medicines Supply Disruptions The recording of the MHRA webinar on managing medicines supply disruptions is now available. Recording Available: MHRA Webinar on Managing Medicines Supply Disruptions
Northern Ireland General Product Safety Regulation Guidance The Office for Product Safety & Standards has issued a GPSR guidance. Northern Ireland General Product Safety Regulation Guidance
HMPWG – Revised Q&A on Quality of Homeopathic Medicinal Products Published The revised Homeopathic Medicinal Products Working Group (HMPWG) questions and answers document on the quality of homeopathic medicinal products (Q 14-15) – possible contaminants nitrosamines has been published. HMPWG – Revised Q&A on Quality of Homeopathic Medicinal Products Published
Update to MHRA’s Q&A on Labelling and Packaging of Medicinal Products for Human Use Following Agreement of Windsor Framework MHRA has published an update to its labelling and packaging of medicinal products for human use following agreement of the Windsor Framework Q&A document. The update includes additional questions and sub-sections. Update to MHRA’s Q&A on Labelling and Packaging of Medicinal Products for Human Use Following Agreement of Windsor Framework
