EMA
Stories
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EMA Management Board highlights September 2026 meeting
The EMA Management Board reviewed its mid-year report and progress on new pharmaceutical legislation during the September 2026 meeting. It noted 29 new human medicine applications, seven veterinary applications, and that the Clinical Trials Information System has supported more than 14,000 trials with over 200 new applications each month.
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EMA endorses ICMRA joint statement on animal testing alternatives
EMA has endorsed a joint statement from the International Coalition of Medicines Regulatory Authorities (ICMRA) calling on medicine developers, manufacturers, regulators and national control laboratories to advance alternative methods to animal testing throughout the medicine lifecycle. The statement sets a long-term goal of replacing animal testing at all stages, from initial candidate screening to post-authorisation activities.
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EMA sets end-of-year submission dates for type I variations in 2026
EMA advises marketing authorisation holders to submit type IA annual updates, individual type IA and type IA IN variations, and super-groupings no later than 20 November 2026. Submissions received after 20 November will still be processed, but the outcome may not be issued until January 2027.
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PRAC carries out safety assessment duties at its 28 September - 1 October meeting
The Pharmacovigilance Risk Assessment Committee (PRAC) reviewed 9 safety signals, 85 periodic safety update reports, 49 risk management plans and 16 post-authorisation safety studies. No referral procedures were started, ongoing or concluded during the meeting.