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News Archive
MHRA - Decentralised Manufacture Guidance Documents
11th June 2025Updated and published guidance on decentralised manufacture released.
MHRA - Human medicines Modular Manufacture and Point of Care regulations 2025: Overview
11th June 2025Information to help you understand and prepare for the main regulatory changes that The Human Medicines (Amendment) Modular Manufacture and Point of Care regulations 2025 will introduce for the manufacture of medicines at - or close to - the point of patient care.
MHRA - Documentation for implementation of data requirements under the new Post-Market Surveillance regulations
10th June 2025Documentation changed to support changes to Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs)
MHRA - MHRA launches new digital hub in Leeds to drive innovation and regional growth
6th June 2025A new digital hub in Leeds is being launched by the Medicines and Healthcare products Regulatory Agency (MHRA), marking a significant step in the agency’s long-term commitment to advancing innovation and strengthening its presence across the UK.
MHRA - RegulatoryConnect Webinar Added
5th June 202522nd May 2025 Webinar added to page
MHRA Blog - A Voyage in Good Distribution Practice (GDP): The Aviation and Marine Sectors
4th June 2025Blog post by Dr Christopher Watson, 4 June 2025
FDA - FDA Launches Agency-Wide AI Tool to Optimise Performance for the American People
3rd June 2025The U.S. Food and Drug Administration (FDA) launches Elsa.
EMA - Veterinary Medicines Highlights
2nd June 2025May 2025 Quarterly news, activities and interviews from EMA Veterinary Medicines Division
MHRA - Digital mental health technology webinar
2nd June 2025The Wellcome Trust has funded a 3-year project focusing on effective regulation and evaluation of digital mental health technology.
MHRA - MHRA Licensing National assessment procedure for medicines webinar
2nd June 2025Recording from 6th May 2025 now available
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