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Use of artificial intelligence in medicines’ lifecycle
Artificial intelligence |RegulatoryUse of artificial intelligence in medicines’ lifecycle
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Use of artificial intelligence in medicines’ lifecycle
Artificial intelligence |RegulatoryUse of artificial intelligence in medicines’ lifecycle
Draft reflection paper for public consultation on regulators’ views on artificial intelligence for the development, use and regulation of human and veterinary medicines
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EU steps up action to prevent shortages of antibiotics
Antibiotics |ShortagesEU steps up action to prevent shortages of antibiotics
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EU steps up action to prevent shortages of antibiotics
Antibiotics |ShortagesEU steps up action to prevent shortages of antibiotics
Joint statement from EMA, the European Commission and the Heads of Medicines Agencies (HMA)
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Safety review ongoing for GLP-1 receptor agonists
Medicines |SafetySafety review ongoing for GLP-1 receptor agonists
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Safety review ongoing for GLP-1 receptor agonists
Medicines |SafetySafety review ongoing for GLP-1 receptor agonists
EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts with medicines used for weight loss and for treating type 2 diabetes
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End of COVID-19 regulatory flexibilities
COVID-19 |Regulatory newsEnd of COVID-19 regulatory flexibilities
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End of COVID-19 regulatory flexibilities
COVID-19 |Regulatory newsEnd of COVID-19 regulatory flexibilities
EMA, EC and HMA are phasing out extraordinary regulatory flexibilities which were introduced during the pandemic to help address regulatory and supply challenges
Latest news
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List item19/07/2023
Reflection paper on the use of artificial intelligence in the lifecycle of medicines
EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open...
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List item17/07/2023
European Health Union: EU steps up action to prevent shortages of antibiotics for next winter
The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency are today issuing recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the...
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List item14/07/2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023
CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6, the Committee adopted, by consensus, a positive opinion for a marketing authorisation for Yurvac RHD , from Laboratorios Hipra, S.A., a new vaccine for the active...
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List item11/07/2023
EMA statement on ongoing review of GLP-1 receptor agonists
EMA’s safety committee, the PRAC, is reviewing data on the risk of suicidal thoughts and thoughts of self-harm with medicines known as GLP-1 receptor agonists, 1 including Ozempic (semaglutide), Saxenda (liraglutide) and Wegovy (semaglutide). These...
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List item07/07/2023
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 3 - 6 July 2023
At its monthly meeting, EMA’s safety committee (PRAC) carried out its broad range of responsibilities, which cover all aspects of the risk management of the use of medicines: assessment of safety signals, risk management plans, periodic safety...
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List item05/07/2023 COVID-19
Global regulators confirm good safety profile of COVID-19 vaccines
EMA has just endorsed a joint statement on the safety of COVID-19 vaccines issued by the International Coalition of Medicines Regulatory Authorities (ICMRA) . Evidence from more than 13 billion doses of COVID-19 vaccines administered worldwide shows...
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