Major update of the SME user guide – www.ema.europa.eu

www.ema.europa.eu The revised user guide offers comprehensive information on the EU legislative framework for medicines, outlining requirements for the development and authorisation of medicines for human and veterinary use. It follows the chronological stages of...

Human medicines: highlights of 2023 – www.ema.europa.eu

www.ema.europa.eu In 2023, EMA recommended 77 medicines for marketing authorisation. Of these, 39 had a new active substance which had never been authorised in the European Union (EU) before. Among these are a number of medicines that stand out due to their...