European Medicines Agency (EMA) The European Medicines Agency is a decentralised agency of the European Union responsible for the evaluation, supervision and safety monitoring of medicines
Medicines | European Medicines Agency (EMA) The European Medicines Agency (EMA) facilitates development and access to medicines for countries within the European Union (EU) EMA evaluates applications for marketing authorisation submitted via the centralised procedure, monitors the safety of medicines across their lifecycle and provides information to healthcare professionals and patients
Human regulatory: overview | European Medicines Agency (EMA) Information on the regulation of medicines for human use in the European Union (EU), with a focus on the centralised procedure The European Medicines Agency (EMA) plays a key role in this procedure
Scientific guidelines - European Medicines Agency (EMA) The European Medicines Agency's Committee for Medicinal Products for Human Use prepares scientific guidelines in consultation with regulatory authorities in the European Union (EU) Member States, to help applicants prepare marketing authorisation applications for human medicines Guidelines reflect a harmonised approach of the EU Member States and the Agency on how to interpret and apply the
Search | European Medicines Agency (EMA) The European Medicines Agency (EMA) makes training and supporting materials available to help users of the Clinical Trials Information System (CTIS) comply with their legal obligations
National registers of authorised medicines - European Medicines Agency . . . The national medicine registers in the different Member States of the European Union (EU) and European Economic Area (EEA) contain information on medicines authorised in those countries, including links for the summary of product characteristics (SmPC) and the package leaflet
Marketing authorisation | European Medicines Agency (EMA) The European Medicines Agency (EMA) is responsible for the scientific evaluation of centralised marketing authorisation applications (MAA) Once granted by the European Commission, the centralised marketing authorisation is valid in all European Union (EU) Member States, Iceland, Norway and Liechtenstein
Home - Clinical Data Publication EMA is the first regulatory authority worldwide to provide such broad access to clinical data For more information on the clinical data on this website, see Clinical data available For more information on EMA and its policy on the publication of clinical data, see the EMA corporate website
Human medicines in 2025 | European Medicines Agency (EMA) In 2025, EMA recommended 104 medicines for marketing authorisation Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before This includes medicines representing important innovation or contribution to public health, such as the first medicine to treat non-cystic fibrosis bronchiectasis, a first-in-class treatment to delay the onset of stage 3