title: [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.
authors.affiliation: Afdeling for Laegemiddelgodkendelse, Laegemiddelstyrelsen, Frederikssundsvej 378, DK-2700 Brønshøj.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Ainsworth
mesh_terms: D002986:Clinical Trials as Topic; D017277:Drug Approval / Q000458:organization & administration*; D004345:Drug Industry; D015507:Drugs, Investigational; D005060:Europe; D005062:European Union; D017408:Guidelines as Topic; D006801:Humans; D007390:International Agencies; D007391:International Cooperation
chemical_list: D015507:Drugs, Investigational