a1 Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Verona, Italy
In Europe, new medicines are approved or rejected on the basis of the results of studies carried out by the manufacturer and submitted to the European Medicines Agency (EMA). This article briefly presents the main roles and responsibilities of the EMA and the key rules that govern the approval process. The main scientific limitations of this process are highlighted, together with some suggestions for dealing with them.
(Received March 05 2012)
(Revised March 15 2012)
(Accepted March 18 2012)
(Online publication April 20 2012)
c1 Address for correspondence: Professor Corrado Barbui, Department of Public Health and Community Medicine, Section of Psychiatry, University of Verona, Piazzale L.A. Scuro, 10-37134 Verona, Italy. (Email: firstname.lastname@example.org)
This Section of Epidemiology and Psychiatric Sciences regularly appears in each issue of the Journal to cover methodological aspects related to the design, conduct, reporting and interpretation of clinical and epidemiological studies. The aim of these Editorials is to help developing a more critical attitude towards research findings published in international literature, promoting original research projects with higher methodological standards, and implementing the most relevant results of research in every-day clinical practice.
Corrado Barbui, Section Editor and Michele Tansella, Editor EPS