European Medicines Agency (EMA)

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Safety committee meeting: May 2025 highlights

New recommendations on finasteride and Ixchiq vaccine

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New safety recommendations on finasteride and dutasteride

Measures minimise risk of suicidal thoughts

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Leveraging large volumes of data and new tools for public and animal health

EU regulators agree workplan to optimise use of data and AI

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Safety review of chikungunya vaccine Ixchiq started

Vaccine must not be used in people 65 years and above

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Streamlining development and assessment of biosimilar medicines

Public consultation open until end September 2025

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EU medicines agencies’ network strategy to 2028

Seizing opportunities in a changing medicines landscape

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Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 13-15 May 2025

Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting

16 May 2025

ETF recommends updating COVID-19 vaccines to target new LP.8.1 variant

Updated vaccines will help maintain protection against disease as virus continues to evolve

16 May 2025

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 5-8 May 2025

Review of medicines containing finasteride and dutasteride concluded

8 May 2025

Measures to minimise risk of suicidal thoughts with finasteride and dutasteride medicines

Suicidal thoughts confirmed as side effect of finasteride tablets; no direct link found for dutasteride

8 May 2025

Data streams pictured as multitude of interconnecting points

Leveraging the power of data for public and animal health

EU regulators agree workplan to optimise use of data and artificial intelligence (AI)

7 May 2025

EMA starts review of Ixchiq (live attenuated chikungunya vaccine)

Vaccine must not be used in people 65 years and above while review is underway

7 May 2025

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Events

19 May2025

Committee for Medicinal Products for Human Use (CHMP): 19-22 May 2025

European Medicines Agency, Amsterdam, the Netherlands

Start date: 19 May 2025

End date: 22 May 2025

19 May2025

Questions and answers clinic on Product Management Service (PMS) Product User Interface (PUI) and Application Programming Interface (API) - May 2025

Online

European Medicines Agency, Amsterdam, the Netherlands

Live broadcast

Start date: 19 May 2025, 15:00 (CEST)

End date: 19 May 2025, 16:00 (CEST)

20 May2025

Paediatric Committee (PDCO): 20-23 May 2025

Online

European Medicines Agency, Amsterdam, the Netherlands

Start date: 20 May 2025

End date: 23 May 2025

21 May2025

Meeting of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) – May 2025

Online

European Medicines Agency, Amsterdam, the Netherlands

Start date: 21 May 2025, 10:00 (CEST)

End date: 21 May 2025, 11:30 (CEST)

22 May2025

Clinical Trials Information System (CTIS): Information day

The European Medicines Agency (EMA) is organising this webinar to provide an in-depth overview of the Clinical Trials Information System (CTIS), its optimisations, best practices, and upcoming developments.

Online

European Medicines Agency, Amsterdam, the Netherlands

Live broadcast

Start date: 22 May 2025, 12:30 (CEST)

End date: 22 May 2025, 17:30 (CEST)

22 May2025

ADRA project - information session for veterinary pharmaceutical industry

Online

European Medicines Agency, Amsterdam, the Netherlands

Start date: 22 May 2025, 14:30 (CEST)

End date: 22 May 2025, 16:00 (CEST)

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