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Single-arm trials as pivotal evidence for the authorisation of medicines in the EU

21 april 2023

News Human Data on medicines Medicines

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 April 2023

14 april 2023

News Human Pharmacovigilance Referrals

Reducing risks to human and animal health from exposure to N-methyl pyrrolidone in veterinary medicines

14 april 2023

News Veterinary Pharmacovigilance Referrals

New features further strengthen Priority Medicines scheme (PRIME)

4 april 2023

News Human Medicines Research and development

EMA business hours over Easter holiday

4 april 2023

News Corporate

EU recommendations for 2023-2024 seasonal flu vaccine composition

4 april 2023

News Human Vaccines

Regulatory information – adjusted fees for applications to EMA from 1 April 2023

31 maart 2023

News Corporate

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27 - 30 March 2023

31 maart 2023

News Human COVID-19 Medicines Vaccines

EMA recommends approval of Bimervax as a COVID-19 booster vaccine

30 maart 2023

News Human COVID-19 Medicines Vaccines

DARWIN EU® has completed its first studies and is calling for new data partners

28 maart 2023

News Human Data on medicines Medicines