The European Medicines Agency 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 Agency brings together 40 national competent authorities in 30 EU and EEA-EFTA countries, represented by over 4,000 European experts.

The EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies must submit a single marketing authorisation application to the EMA. All medicinal products for human and animal use derived from biotechnology and other high-technology processes must be approved via the centralised procedure. The safety of medicines is constantly monitored by the Agency through a pharmacovigilance network. The system has been strengthened with the introduction of the pharmacovigilance legislation. The Agency is also involved in referral procedures relating to medicinal products that are approved or under consideration by Member States.

In 2001, the Committee for Orphan Medicinal Products (COMP) was established, charged with reviewing designation applications for rare diseases. The EMA is also committed to promote the availability of medicines for rare diseases and stimulate medicines development in this area.