Methods and Findings in Experimental and Clinical Pharmacology
Vol. 25, Suppl. A, 2003
ISSN 0379-0355
Copyright 2003 Prous Science, S.A.
CCC: 0379-0355/2003
http://www.prous.com

Regulatory Issues in Psychopharmacology.
European Union Perspective*

G. Calvo

Hospital Clínic de Barcelona, Spanish Agency on Medicines, Member of the Committe for Proprietary Medicinal Products (CPMP)

Since the creation of the EMEA in 1995, the Committee for Proprietary Medicinal Products (CPMP), throughout its different working parties, has developed regulatory guidance documents on the different steps of drug development: quality, non-clinical and clinical issues. The European regulatory system is the result of the sum of the Regulatory Agencies from the EU Member States. Therefore, these guidelines are not only aimed at providing regulatory advice to pharmaceutical companies, but are also a crucial tool for maintaining consistency in the CPMP opinions across time, harmonizing the regulatory evaluation criteria across the EU Member States, and assuring transparency on the criteria applied during the regulatory assessment.

Among the duties of the Efficacy Working Party (CPMP-EWP), drafting recommendations on the clinical development of new drugs is probably the most relevant and publicly known. These EWP guidance documents, jointly with the CPMP-Scientific Advice procedure, are the main tools that pharmaceutical companies have for trying to adjust their clinical development programs for new drugs to the CPMP requirements. This is a dynamic exercise where guidance documents are drafted and updated according to necessities that arise from regulatory experience and moving scientific knowledge.

Regulatory activities within the EU arise from different cultural, social, medical and regulatory backgrounds among Member States. These differences acquire special relevance in clinical aspects, although the magnitude of such divergences is strongly dependent on the therapeutic field we are dealing with. In this regard, neuropharmacology, and more specifically, psychopharmacology are therapeutic fields in which geographical differences within the EU are particularly pronounced and thus the need for harmonization strongly required.

This presentation will deal with relevant issues on the regulatory requirements for the clinical development of psychoactive drugs, focusing on antipsychotics, antidepressants, mood stabilizers and anxiolytics. Aspects such as the use of placebo, the design of pivotal studies, the choice of the comparator, and the extrapolability of the results from clinical trials will be discussed from the perspective of each claimed therapeutic indication, even within the same disease.

*Publication Disclaimer: The views presented are these of the author and may not be understood or quoted as to be made on behalf of the CPMP or reflect the position of the CPMP.

Methods and Findings in Experimental and Clinical Pharmacology Vol. 25, Suppl. A, 2003
ISSN 0379-0355 Copyright 2003 Prous Science, S.A. CCC: 0379-0355/2003 http://www.prous.com