Europe and medicines: role of the EMEA

F. Sauer. Ann Pharm Fr 2000, 58: 278-285. The new European authorization system has made considerable progress since 1995. The European Agency for the Evaluation of Medicinal Products (EMEA) is primarily responsible for the scientific evaluation of applications for a European marketing authorization for medicinal products derived from biotechnology and other high technology (centralised procedure). For other products, the EMEA arbitrates where mutual recognition of national marketing authorizations between the Member States is not possible (decentralised procedure). The EMEA co-ordinates the scientific resources made available by the national competent authorities of the Member States, including a network of over 2 000 European experts. The Opinions of the scientific committees of the EMEA (Committee for Proprietary Medicinal Products, CPMP, and Committee for Veterinary Medicinal Products, CVMP) are enforced by the European Commission, which has so far authorized 69 medicinal products for human and veterinary use. The confidence of industry, health professionals and consumers in the system is clear. European patients are now able to have speedier access to new drugs, usually within one year. The new system also helps to reinforce the safety of medicines for humans and animals, particularly through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals.