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Management Board: Highlights of March 2023 meetingManagement Board |Highlights
Management Board: Highlights of March 2023 meeting
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Management Board: Highlights of March 2023 meetingManagement Board |Highlights
Management Board: Highlights of March 2023 meeting
The Board received updates on the Agency’s extended mandate and the recent operational experience with the clinical trials information system
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Highlights of the Safety Committee: March 2023MEDICINES |COMMITTEES
Highlights of the Safety Committee: March 2023
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Highlights of the Safety Committee: March 2023MEDICINES |COMMITTEES
Highlights of the Safety Committee: March 2023
At its monthly meeting, EMA's safety committee, the PRAC, carried out its work to assess all aspects of risk management related to the use of medicines.
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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 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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List item24/02/2023 COVID-19
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20 - 23 February 2023
Eight new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended granting a marketing authorisation for Akeega (niraparib/abiraterone acetate) for the treatment of metastatic castration-resistant prostate cancer with...
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List item17/02/2023
Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 14-16 February 2023
CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6 The Committee adopted by consensus positive opinions for variation requiring assessment to align the product information with version 9.0 of the QRD template for: Bravecto...
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List item16/02/2023
Veterinary medicines: highlights of 2022
EMA has published an overview of its key recommendations of 2022 regarding the authorisation and safety monitoring of veterinary medicines. In 2022, EMA recommended ten medicines for marketing authorisation. Of these, three had a new active...
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Key content
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