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Regulatory policies on medicines for psychiatric disorders: is Europe on target?

Department of Medicine and Public Health, University of Verona, Verona

SILVIO GARATTINI

Institute of Pharmacological Research Mario Negri, Milan, Italy

Correspondence: Dr Corrado Barbui, Department of Medicine and Public Health, Section of Psychiatry and Clinical Psychology, Ospedale Policlinico, 37134 Verona, Italy. Tel: +39 045 8076418; fax: +39 045 585871; email: corrado.barbui{at}univr.it

Declaration of interest S.G. was a member of the Committee for Proprietary Medicinal Products.

The European Medicines Agency (EMEA) is the regulatory body that provides the institutions of the European Community with the best possible scientific advice on the quality, safety and efficacy of medicinal products. Drugs approved by the EMEA are automatically marketable in all the European member states. Since the beginning of the EMEA’s activities a number of drugs acting on the central nervous system obtained marketing authorisation. This editorial highlights some aspects of the EMEA rules that may negatively affect the evaluation of medicines for psychiatric disorders.

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