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The European Medicines Agency (EMA) has released a major revision of its user guide for micro, small, and medium-sized enterprises (SMEs) in the pharmaceutical sector.
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NewsVeterinaryMedicines
In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their contribution to address public health needs or the innovation they represent.
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Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
NewsHumanPharmacovigilanceReferrals
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.
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The midterm report of the European Medicines Agencies Network Strategy (EMANS) finds the pandemic strengthened the network and supported transformative change in the European system across key strategic areas.
NewsCorporate
The European Medicines Agency's (EMA) office is closed from 18:30 on Friday 22 December 2023 to 07:30 on Wednesday 3 January 2024.
NewsCorporate
EMA's Executive Director, Emer Cooke, shares her end-of-year message and takes stock of EMA's work in 2023.
NewsCorporate
EMA and the Heads of Medicines Agencies (HMAs) have published an artificial intelligence (AI) workplan to 2028, setting out a collaborative and coordinated strategy to maximise the benefits of AI to stakeholders while managing the risks.
NewsCorporateData on medicines
The Board adopted EMA’s work programme for 2024, acknowledging that the Agency will continue to deliver on all its strategic priorities.
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