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News Archive
EMA Management Board Highlights: October 2025
10th October 2025The European Medicines Agency (EMA) Management Board convened on 2nd October 2025, reviewing mid-year performance and endorsing strategic initiatives.
EMA Seeks Public Input on Enhancing Patient Perspectives in Medicine Regulation
10th October 2025The European Medicines Agency (EMA) has released a draft reflection paper inviting public consultation on integrating patient experience data into the regulatory process.
EMA's PRAC Meeting Highlights: 29th September – 2nd October 2025
10th October 2025The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) convened from 29th September to 2nd October 2025, addressing various aspects of medicine safety.
FDA Issues Final Guidance on Assessing Drug Manufacturing Facilities Using Alternative Tools
10th October 2025The FDA has finalised guidance on employing alternative tools to evaluate drug manufacturing facilities in pending applications.
MHRA Patient Safety Essay Competition 2025
10th October 2025The MHRA invites medical students and foundation doctors to explore how genetics can enhance prescribing safety and patient outcomes in the UK.
MHRA Updates Guidance on Clinical Trials Involving In Vitro Diagnostic Devices
10th October 2025The MHRA has released updated guidance for conducting clinical trials that include in vitro diagnostic (IVD) devices.
MHRA Updates Guidance on Clinical Trials Requiring Expert Advice
10th October 2025The MHRA has released updated guidance for clinical trials that necessitate expert advice from specialist groups or committees.
MHRA Updates Guidance on Clinical Trials: Collection, Verification, and Reporting of Safety Events
10th October 2025The MHRA has released an updated version of its guidance on safety event management in clinical trials.
MHRA Updates Guidance on Ending Clinical Trials
10th October 2025The MHRA has released updated guidance on the process for ending clinical trials, effective from 28th April 2026.
MHRA Updates Guidance on Modifying Clinical Trial Approvals: Introduction of Route A and B Processes
10th October 2025The MHRA has updated its guidance on modifying clinical trial approvals, introducing Route A and B processes to streamline amendments.
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