www.ema.europa.eu Preparedness for intensified monitoring, methodologies based on established pharmacovigilance tools as well as on innovative approaches and the flexibility and commitment of all the stakeholders involved were key factors to allow the European medicines regulatory...

www.ema.europa.eu CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6The Committee adopted the scientific advice on the establishment of a list of antimicrobials which shall not be used in accordance with Articles 112, 113 and 114 of Regulation (EU) 2019/6 or which...

www.ema.europa.eu EMA’s Management Board met on 7-8 June in Amsterdam.The European Commission informed the Board about its legal proposals to revise the pharmaceutical legislation, published on 26 April, which aim to make the EU regulatory framework fit for innovative medicines, support...

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 The European Centre for Disease Prevention and Control (ECDC) and the European Medicines Agency (EMA) have issued a joint statement on adapted COVID-19 vaccines and considerations for their use during the upcoming autumn 2023 vaccination campaigns. Currently authorised...

www.ema.europa.eu Today, the European Union (EU) and the United States (US) have made important progress towards enabling mutual recognition of inspections of manufacturing facilities of certain veterinary products. The Food and Drug Administration (FDA) has recognised the capability of 16...