www.ema.europa.eu Crisis preparedness and response The Management Board welcomed EMA’s support to African regulators in the context of the Ebola outbreak in the Democratic Republic of Congo and Uganda caused by the Bundibugyo virus. This is the first public health emergency where EMA’s...

www.ema.europa.eu PRAC concludes evidence of potential risk of neurodevelopmental disorders in children born to men treated with valproate is inconsistent   Committee recommends updating product information to reflect available data  EMA’s safety committee, the PRAC, has completed its...

www.ema.europa.eu Today, EMA released its 2025 annual report, highlighting progress in bringing innovative, safe and effective medicines to patients. The report outlines the most important achievements in evaluating and monitoring human and veterinary medicines along with a selection of key...

www.ema.europa.eu EMA’s Emergency Task Force (ETF) is engaging with the African Medicines Agency (AMA) and its national regulatory authorities (NRAs), leveraging expertise from the WHO-AFRO African Vaccines Regulatory Forum (AVAREF), to discuss possible clinical trial designs and medical...

www.ema.europa.eu EMA staff will be joined on the boat by representatives of patient organisations such as EURORDIS-Rare Diseases Europe, European AIDS Treatment Group (EATG) and the European Patient Forum (EPF) to underline the commitment to collaboration and inclusion of diverse...