www.ema.europa.eu Two new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended two medicines for approval at its June 2023 meeting.The committee recommended granting a marketing authorisation for Aquipta (atogepant), intended for the prophylaxis of migraine...

www.ema.europa.eu The Accelerating Clinical Trials in the EU (ACT EU) initiative is today organising the kick-off workshop for a new multi-stakeholder platform to improve clinical trials in the European Union (EU). ACT EU is a collaboration between EMA, the Heads of Medicines Agencies (HMA)...

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...