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 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.
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.
For medicinal products that do not fall under any of the above-mentioned categories companies can submit an application for a centralised marketing authorisation to the EMA, provided the medicinal product constitutes a significant therapeutic, scientific or technical innovation or the product is in any other respect in the interest of patient or animal health.
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.
The Agency also has a role to stimulate innovation and research in the pharmaceutical sector. The EMA gives scientific advice and protocol assistance to companies for the development of new medicinal products. It publishes guidelines on quality, safety and efficacy testing requirements. A dedicated office established in 2005 provides special assistance to small and medium-sized enterprises (SMEs).
In 2001, the Committee for Orphan Medicinal Products (COMP) was established, charged with reviewing designation applications from persons or companies who intend to develop medicines for rare diseases (so-called ‘orphan drugs’). The Committee on Herbal Medicinal Products (HMPC) was established in 2004 and provides scientific opinions on traditional herbal medicines.
The Agency brings together the scientific resources of over 40 national competent authorities in 30 EU and EEA-EFTA countries in a network of over 4,000 European experts. It contributes to the European Union’s international activities through its work with the European Pharmacopoeia, the World Health Organization, and the ICH and VICH trilateral (EU, Japan and US) conferences on harmonisation, among other international organisations and initiatives.
The EMA is headed by the Executive Director and has a secretariat of about 440 staff members in 2007. The Management Board is the supervisory body of the EMA, responsible, in particular, for budgetary matters.
The Agency is also involved in referral procedures relating to medicinal products that are approved or under consideration by Member States.
Deputy Executive Director: