www.ema.europa.eu EMA has opened a public consultation on a reflection paper that discusses key concepts for single-arm clinical trials that are submitted as pivotal evidence in support of marketing authorisation applications for medicines in the European Union (EU). This is the first...

www.ema.europa.eu 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 update reports and...

www.ema.europa.eu On 8 December 2022, EMA’s veterinary medicines committee, the CVMP, recommended new measures to reduce the risks from exposure to the excipient N-methyl pyrrolidone (NMP) for women who may handle NMP-containing veterinary medicines and animals that are given these...

www.ema.europa.eu EMA is introducing a number of new features to the PRIority Medicines (PRIME) scheme to strengthen its support for the development of medicines in areas of unmet medical needs. The PRIME scheme enables earlier availability of life-changing medicines for patients. By the...

www.ema.europa.eu The European Medicines Agency's (EMA) office is closed from 18:30 on Wednesday 5 April 2023 to 07:30 on Tuesday 11 April 2023.Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is...

www.ema.europa.eu EMA has issued the recommendations for the influenza virus strains that vaccine manufacturers should include in vaccines for the prevention of seasonal influenza from autumn 2023.Manufacturers of egg-based or live attenuated quadrivalent vaccines for the 2023-2024 season...