EMA Guidance on Real-World Evidence Provided by EMA EMA has published a guidance on real-world evidence provided by EMA: support for regulatory decision-making. EMA Guidance on Real-World Evidence Provided by EMA
MHRA Webinar on International Recognition – Post Launch Updates The MHRA is holding a webinar on International Recognition – post-launch updates, which is being held on Thursday 2 May 2024 from 14:30 to 16:00. MHRA Webinar on International Recognition – Post Launch Updates
MHRA Board Meeting – 19 March 2024 The meeting recording and board pack from the MHRA Board Meeting on 19 March 2024 have been published on the MHRA website. MHRA Board Meeting – 19 March 2024
International Recognition Procedure – Supplementary Information Update MHRA has updated the International Recognition Procedure supplementary information guidance. International Recognition Procedure – Supplementary Information Update
MHRA Webinar on Established Medicines Licensing MHRA is running a webinar on established medicines licensing, which is being held from 11:00am – 12:00pm (BST) on Wednesday 24 April 2024. MHRA Webinar on Established Medicines Licensing
MHRA Publishes Guidance on UK Parallel Import Licences Post-Windsor Agreement MHRA's latest guidance outlines changes to UK Parallel Import Licences post-Windsor Agreement. Learn about the new regulations here. MHRA Publishes Guidance on UK Parallel Import Licences Post-Windsor Agreement
EMA HMPC Calls for Scientific Data: Periodic Reviews of Herbal Monographs The European Medicines Agency's (EMA) Committee on Herbal Medicinal Products (HMPC) has launched calls for submission of scientific data. EMA HMPC Calls for Scientific Data: Periodic Reviews of Herbal Monographs
CMDh Meeting Highlights: March 2024 Key updates from the CMDh meeting held on March 19-20 2024, including procedural advice, pharmacovigilance, and marketing authorisation variations. CMDh Meeting Highlights: March 2024
AESGP Position Paper on the Transition of Patient Information AESGP, the Association of the European Self-Care Industry, has published a position paper 'From Paper to Digital - AESGP Position Paper on the transition of patient information'. AESGP Position Paper on the Transition of Patient Information
MHRA Newsletter Published – March 2024 The MHRA has published the latest edition of its industry newsletter. MHRA Newsletter Published – March 2024
Windsor Framework Q&A Publications The MHRA has published a new Q&A document to support the UK-wide licensing for human medicines guidance. Additionally, the Q&A document related to the labelling and packaging of medicinal products for human use following agreement of the Windsor Framework has been updated. Windsor Framework Q&A Publications
Nitrosamines – Updated Q&A Appendix 3 The European Medicines Agency (EMA) has published the Appendix 3 to Questions and answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. Nitrosamines – Updated Q&A Appendix 3
