Our summary of the European Medicines Agency’s (EMA) Human Medicines Highlights issue of March 2025.
Key Updates:
- EMA Network Strategy to 2028 (EMANS 2028): the EMA has published an updated strategy outlining the European medicines regulatory network’s direction for the coming years. This strategy aims to address challenges such as public health emergencies and antimicrobial resistance. Click here for more details.
- Warning against unregulated advanced therapy medicinal products (ATMPs): the EMA and national medicine agencies caution the public about unregulated ATMPs, which include therapies based on genes, cells, or tissues. While authorised ATMPs offer significant benefits, unauthorised versions, often promoted online, pose health risks. Suspicious cases should be reported to national competent authorities. Click here for more details.
- Launch of clinical trial map: as part of the Accelerating Clinical Trials in the EU (ACT EU) initiative, the EMA has introduced a clinical trial map to provide patients and healthcare professionals with real-time information about ongoing clinical trials by geographic area and medical condition. Please click here for more details.
- Updated orphan medicines infographic: the EMA has released an updated infographic and revamped webpage highlighting key figures and information on orphan medicines, which are vital for treating rare neurological disorders. Please click here for more details.
- High risk medical devices: the EMA has established a regular procedure for manufacturers of high-risk medical devices used to administer or remove medicines to seek scientific advice from expert panels on their clinical development programmes. Please click here for more details.
- Medicines: the EMA has announced a shortage of extended-release quetiapine tablets in certain EU Member States until the end of June 2025. Please click here for more details
