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A New and Fast Drug Approval System in Europe

The European Agency for the Evaluation of Medicinal Products (EMEA) has been operational since February 1995. Primarily responsible for the scientific evaluation of applications for biotechnology and other high technology medicinal products in the centralized procedure, the EMEA also arbitrates where mutual recognition of national approvals is not possible in the decentralized procedure. The new European drug approval system appears fast and efficient: within the first one anda half years of operation, some 26 positive opinions for new medicinal products were issued, leading to the granting of European Marketing Authorizations by the commission. The principal scientific committee of the EMEA, the Committee for Proprietary Medicinal Products (CPMP), was able to deliver these opinions within 210 days, and even less in the case of AIDS products. Industry confidence in the new European approval system is clear—two-thirds of the 30 new pending applications are voluntary applications which could have used national routes for authorization.