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
European Commission Webinar on Packaging and Packaging Waste Regulation On 16 December, the European Commission is hosting a webinar on the Packaging and Packaging Waste Regulation (PPWR). European Commission Webinar on Packaging and Packaging Waste Regulation
European Shortages Monitoring Platform Goes Live The European Shortages Monitoring Platform (ESMP) has now gone live. MAHs can now log in and begin using the platform. European Shortages Monitoring Platform Goes Live
MHRA’s Final Call to Comply with Windsor Framework Arrangements for Medicines from January 2025 MHRA is reminding MAHs to ensure they are prepared for the new Windsor Framework packaging and labelling measures for medicines from January 2025. MHRA will be responsible for licensing all medicines on the market in Northern Ireland under a UK-wide licence, and all medicines for the UK market must carry a ‘UK Only’ label or sticker. MHRA’s Final Call to Comply with Windsor Framework Arrangements for Medicines from January 2025
MHRA Marketing Authorisations Granted 1 to 14 November MHRA granted 1 OTC licence during 1 - 14 November 2024. MHRA Marketing Authorisations Granted 1 to 14 November
