The European Medicines Agency (EMA) is a decentralised body of the European Union with headquarters in Amsterdam. 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 EMA is responsible for the scientific evaluation of applications for European marketing authorisation for medicinal products (centralised procedure). Under the centralised procedure, companies submit one single marketing authorisation application to the EMA.
Approval of medicines
All medicinal products for human and animal use derived from biotechnology and other high-technology processes must be approved via the centralised procedure. The same applies to all human medicines intended for the treatment of HIV/AIDS, cancer, diabetes or neurodegenerative diseases and for all designated orphan medicines intended for the treatment of rare diseases. Similarly, all veterinary medicines intended for use as performance enhancers in order to promote the growth of treated animals or to increase yields from treated animals have to go through the centralised procedure.
The safety of medicines is monitored constantly by the Agency through a pharmacovigilance network. The EMA takes appropriate actions if adverse drug reaction reports suggest changes to the benefit-risk balance of a medicinal product. For veterinary medicinal products the Agency has the responsibility to establish safe limits for medicinal residues in food of animal origin.