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EMA will harness its unique experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network.
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Corporate
On 24 January 2024, the CMDh endorsed precautionary measures recommended by EMA’s safety committee (PRAC) for the treatment of male patients with valproate medicines. These measures are to address a potential increased risk of neurodevelopmental disorders in children born to men treated with valproate during the 3 months before conception...
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Human
Referrals
EMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.
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Human
Medicines
Referrals
On 25 January 2024, EMA’s human medicines committee (CHMP) endorsed the measures recommended by the Pharmacovigilance Risk Assessment Committee (PRAC) to minimise the risks of posterior reversible encephalopathy syndrome (PRES) and reversible cerebral vasoconstriction syndrome (RCVS) for medicines containing pseudoephedrine.
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EMA has published an overview of its key recommendations of 2023 regarding the authorisation and safety monitoring of veterinary medicines.
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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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Human
Veterinary
Medicines
SME
News
Veterinary
Medicines
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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Human
Medicines
Potential risk of neurodevelopmental disorders in children born to men treated with valproate medicines: PRAC recommends precautionary measures
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Human
Pharmacovigilance
Referrals
EMA’s safety committee (PRAC) is recommending precautionary measures for the treatment of male patients with valproate medicines.
News
Human
Pharmacovigilance
Referrals