www.ema.europa.eu EMA has published a report from a workshop that collected insights and suggestions for possible EU-level actions to improve the way clinical trials are set up and conducted in the European Union (EU) during public health emergencies. The actions presented in the report aim...

www.ema.europa.eu 14 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 14 medicines for approval at its July 2023 meeting.The CHMP recommended granting a marketing authorisation for Abrysvo (bivalent, recombinant), a vaccine to protect small infants...

www.ema.europa.eu EMA has recommended granting a marketing authorisation in the European Union (EU) for Abrysvo, a vaccine to protect against disease caused by the respiratory syncytial virus (RSV). Abrysvo is the first RSV vaccine indicated for passive immunisation of infants from birth...

www.ema.europa.eu EMA has expanded the scope of the OPEN initiative from COVID-19 vaccines and treatments to a wider range of medicines, such as medicines with the potential to address antimicrobial resistance (AMR), respiratory syncytial virus (RSV) infections or newly diagnosed...

www.ema.europa.eu EMA has published a draft reflection paper outlining the current thinking on the use of artificial intelligence (AI) to support the safe and effective development, regulation and use of human and veterinary medicines. This paper, which is now open for public consultation,...

www.ema.europa.eu The European Commission, the Heads of Medicines Agencies (HMA) and the European Medicines Agency are today issuing recommendations for actions to avoid shortages of key antibiotics used to treat respiratory infections for European patients in the next winter season. These...