The European Medicines Agency (formerly known as EMEA, or now also abbreviated "the Agency" or "EMA") is a decentralised body of the European Union with headquarters in London.

Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use. The European Medicines Agency coordinates the evaluation and supervision of medicinal products throughout the European Union. The European Medicines Agency brings together the scientific resources of some 40 national competent authorities in 30 EU and EEAEFTA countries in a network of over 4,000 European experts. It cooperates closely with international partners, reinforcing the EU contribution to global harmonisation.

The European Medicines Agency began its activities in 1995, when the European system for authorising medicinal products was introduced, providing for a centralised and a mutual recognition procedure. The Agency has a role in both, but is primarily involved in the centralised procedure. Where the centralised procedure is used, companies submit one single marketing authorisation application to the Agency. A single evaluation is carried out through the Committee for Medicinal Products for Human Use (CHMP) or Committee for Medicinal Products for Veterinary Use (CVMP). If the relevant Committee concludes that quality, safety and efficacy of the medicinal product is sufficiently proven, it adopts a positive opinion. This is sent to the Commission to be transformed into a single market authorisation valid for the whole of the European Union.

The European Medicines Agency publishes information on all medicinal products assessed by the CHMP on the Agency's website. Any positive opinion given by the Committee is published in the first instance as a Summary of Opinion. More detailed information is published later, following the granting of a Marketing Authorisation by the European Commission as an European Public Assessment Report (EPAR). The summary, list of authorised presentations and the product information (SPC, labelling and package leaflet) for all authorised presentations are provided in all EU languages on the Agency's Website. The scientific discussion, procedural steps before authorisation and steps taken after authorisation are available in English only.

ECPC is a member of the Agency's Patients' and Consumers' Working Party.

More Information

• European Medicines Agency Website
• Assessment reports (EPARs) of all human medicines approved in the EU
• Patients' and Consumers' Working Party (PCWP)