MHRA – Lorenz Docubridge Validation Tool MHRA has added details of the Lorenz Docubridge validation tool to the guidance 'Medicines: apply for a variation to your marketing authorisation' and 'Apply for a licence to market a medicine in the UK'. MHRA – Lorenz Docubridge Validation Tool
MHRA Newsletter April 2024 MHRA has published the April edition of MHRA News, the monthly newsletter for industry. MHRA Newsletter April 2024
MHRA Performance Data for Assessment of Clinical Trials and Established Medicines The MHRA performance metrics for clinical trials and established medicines assessment have been updated. MHRA Performance Data for Assessment of Clinical Trials and Established Medicines
MHRA Publishes Marketing Authorisations Granted From 15 to 31 March 2024 MHRA granted one new OTC licence between 15 and 31 March. MHRA Publishes Marketing Authorisations Granted From 15 to 31 March 2024
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
