EMA’s office is closed from 18:00 on Wednesday 16 April 2025 to 08:30 on Tuesday 22 April 2025.Outside of working hours and on public holidays, it is possible to call the…

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address…

CVMP opinions on veterinary medicinal productsThe Committee adopted by consensus a positive opinion for a marketing authorisation from Intervet International B.V. for Nobilis…

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:…, Agenda Agenda of the PRAC meeting 7-10 April […]

This news announcement was updated on 9 April 2025 to include a recommendation for a strain for seasonal live attenuated influenza vaccines.EMA has issued recommendations for the…

The Clinical Trials Information System (CTIS) has been designated as a primary registry by the World Health Organisation (WHO) within the International Clinical Trials Registry…

EMA is exploring improvements to the development and evaluation of biosimilar medicines, while upholding strict European Union (EU) safety standards. With over two decades of…

For the first time, all the 27 countries of the European Union (EU27) together with Iceland and Norway, have collected and reported data on both sales and use of antimicrobials in…

Five new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2025 meeting.The committee recommended…, Positive recommendation on new medicine , Xoanacyl […]