[New drugs and European procedures of approval. The European Agency for the Evaluation of Medicinal Products' role]

Abstract

Whereas regulatory drug approval in Europe previously was the responsibility of national authorities, innovative new drugs are now being approved by the European Commission instead. Through its agency for drug evaluation (EMEA), the Commission provides guidance on the clinical documentation necessary to obtain regulatory approval for new drugs. As a large proportion of clinical drug trials is sponsored by industry and aims at obtaining regulatory approval, the guidance provided by EMEA will have increasing influence on clinical drug research in Europe.