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CHMP highlights: March 2023MEDICINES |COMMITTEES
CHMP highlights: March 2023
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CHMP highlights: March 2023MEDICINES |COMMITTEES
CHMP highlights: March 2023
EMA's human medicines committee (CHMP) recommended 9 new medicines for approval in the EU at its March 2023 meeting
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Bimervax recommended for approval in the EUCOVID-19 |Vaccines
Bimervax recommended for approval in the EU
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Bimervax recommended for approval in the EUCOVID-19 |Vaccines
Bimervax recommended for approval in the EU
EMA recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) for use as a booster in people aged 16 years and above
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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
Latest news
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List item31/03/2023
Regulatory information – adjusted fees for applications to EMA from 1 April 2023
The European Medicines Agency (EMA) reminds applicants and marketing authorisation holders that adjusted fees for all applications, except for pharmacovigilance procedures, will be coming into effect on 1 April 2023. Every year, the European...
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List item31/03/2023 COVID-19
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023
Nine new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended nine medicines for approval at its March 2023 meeting. The CHMP recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA)...
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List item30/03/2023 COVID-19
EMA recommends approval of Bimervax as a COVID-19 booster vaccine
EMA’s human medicines committee (CHMP) has recommended authorising the COVID-19 vaccine Bimervax (previously COVID-19 Vaccine HIPRA) as a booster in people aged 16 years and above who have been vaccinated with an mRNA COVID-19 vaccine. Bimervax,...
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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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