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First anniversary of DARWIN EU®Real-world evidence |Regulatory
First anniversary of DARWIN EU®
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First anniversary of DARWIN EU®Real-world evidence |Regulatory
First anniversary of DARWIN EU®
DARWIN EU® has completed its first studies, generating real-world evidence to support regulatory decision making. A call to onboard ten additional data partners in 2023 is now open.
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Achievements of the Regulatory Science StrategyRegulatory Science |Report
Achievements of the Regulatory Science Strategy
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Achievements of the Regulatory Science StrategyRegulatory Science |Report
Achievements of the Regulatory Science Strategy
EMA published a report summarising the mid-term achievements of the Regulatory Science Strategy to 2025
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Human medicines: highlights of 2022Medicines |Highlights
Human medicines: highlights of 2022
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Human medicines: highlights of 2022Medicines |Highlights
Human medicines: highlights of 2022
EMA recommended 89 human medicines for marketing authorisation in 2022. Check out our overview of key recommendations on the authorisation and safety monitoring of human medicines
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Veterinary medicines: highlights of 2022Medicines |Highlights
Veterinary medicines: highlights of 2022
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Veterinary medicines: highlights of 2022Medicines |Highlights
Veterinary medicines: highlights of 2022
EMA recommended 10 veterinary medicines for marketing authorisation in 2022. Check out our overview of key recommendations on the authorisation and safety monitoring of veterinary medicines
Latest news
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List item28/03/2023
DARWIN EU® has completed its first studies and is calling for new data partners
DARWIN EU® , the Data Analysis and Real-World Interrogation Network, has accomplished its first year of establishment. Following the set-up of the DARWIN EU® Coordination Centre in February 2022, the first ten data partners were onboarded. The...
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List item24/03/2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 21-22 March 2023
CVMP opinions on veterinary medicinal products Under Regulation (EC) No 726/2004 The Committee adopted by consensus a positive opinion for a marketing authorisation of Newflend ND H9, from Ceva-Phylaxia Co. Ltd., a new vaccine for the active...
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List item22/03/2023
Advancing regulatory science in the EU – mid-point report published
EMA has published a report summarising the mid-term achievements of its Regulatory Science Strategy (RSS) to 2025 . The report provides an overview of the main deliverables achieved between March 2020 and December 2022 across the human and...
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List item17/03/2023
EMA Management Board: highlights of March 2023 meeting
The Management Board was updated on the ongoing efforts of EMA’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to closely monitor several critical shortages of medicines in the EU/EEA, in particular medicines...
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List item17/03/2023
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 13 - 16 March 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 item27/02/2023
EMA pilots scientific advice for certain high-risk medical devices
EMA has launched a pilot to give scientific advice on the intended clinical development strategy and proposals for clinical investigation for certain high-risk medical devices (all class III devices and class IIb active devices intended to...
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Services & databases
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Clinical Trials website
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Account Management portal
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eSubmission
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EudraVigilance (human)
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EudraVigilance Veterinary
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Veterinary Medicines information website
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Suspected adverse drug reactions database
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Clinical data
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SPOR data management services
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Service Desk
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IRIS platform
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Public register of parallel distribution notices
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European Vaccination Information Portal