European Medicines Agency
ema.europa.eu
Imported from official source
European Union body; safety publications from its own official source.
- Type
- Regulator
- Scope
- EU · supranational
- Website
- ema.europa.eu
- Feed
- Atom
Publications 10
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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 28 September - 1 October
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities to manage the safety of medicines, including the assessment of safety…, Agenda Agenda of t...
Announcement Safety -
Advice on ‘end-of-year’ submission dates for type I variations in 2026
Marketing authorisation holders wishing to receive an outcome in 2026 should submit type IA annual updates, individual type IA and type IAIN variations, and super-groupings…
Announcement Safety -
EMA Management Board: highlights of September 2026 meeting
Mid-year report 2026 from the Executive DirectorEMA presented results and achievements of its operations for the first half of 2026 to the Management Board. Between January and…
Announcement -
Global regulators call for advancing alternatives to animal testing across the medicine lifecycle
EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and…
Announcement Safety -
Executive Director speech at EMA women’s health multi-stakeholder workshop
Amsterdam, 28 September 2026Check against delivery (The published text is based on the prepared speech. Minor differences may have occurred during delivery)Good morning,…
Announcement -
Women are missing from medicines development: EMA’s roadmap for change
By the end of 2026, EMA will develop a regulatory roadmap to help drive decisive change on how women’s health is considered across medicines development and regulation. This…, Women are still missi...
Announcement Safety -
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 September 2026
12 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 12 medicines for approval at its September 2026 meeting.The committee recommended…, CHMP statistics Key f...
Announcement Safety -
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 8-10 September 2026
CVMP opinions on veterinary medicinal products The Committee adopted a positive opinion for a marketing authorisation for Cirbloc, for the active immunisation of pigs from…
Announcement Safety -
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 31 August - 3 September 2026
Review will assess risk of low blood phosphate levels and related bone problems with injectable iron medicinesEMA’s safety committee, PRAC, has started a review of injectable…, Agenda Agenda of the...
Announcement Safety -
New EU supply chain to end Visudyne shortage
A new supply chain for Visudyne (verteporfin) has been put in place in the European Union (EU), marking an important step towards resolving a long-standing shortage of the…, This situation shows th...
Announcement Safety