www.ema.europa.eu This year, European Immunization Week, marked between 23 and 29 April, reminds us about the importance of timely routine vaccination and why we need to catch up on any missed or postponed vaccines and booster doses.Several routine vaccines are available for all age groups...

www.ema.europa.eu CVMP opinions on veterinary medicinal productsUnder Regulation (EU) 2019/6The Committee adopted by consensus a positive opinion for a variation requiring assessment for Gumbohatch (live Avian infectious bursal disease vaccine) concerning the amendment of the indication by...

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...