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Vol. 18 - Num. 72

Special Articles

New regulation of clinical essays using pharmaceuticals in Spain

Elena Molina Martína, M.ª Luisa Arroba Basantab

aFarmacéutica de Atención Primaria. Servicio Madrileño de Salud. Madrid. España.
bDepartamento de Salud Pública y Materno-Infantil. Universidad Complutense de Madrid. Pediatra. CS Pozuelo-Emisora. Pozuelo de Alarcón. Madrid. España.

Correspondence: E Molina. E-mail:

Reference of this article: Molina Martín E, Arroba Basanta ML. New regulation of clinical essays using pharmaceuticals in Spain. Rev Pediatr Aten Primaria. 2016;18:e229-e237.

Published in Internet: 16-11-2016 - Visits: 10059


The new European regulation of clinical essays using pharmaceuticals brings a series of changes in the authorization procedures in the Union and the emergence of new definitions and concepts that binds every member state to carry out modifications in their laws. The goal of this changes is to promote the carrying out of this kind of clinical trials.

In order to accomplish that, the administrative procedures needed for this studies to be designed and take place have been made easier. The developer is only required to present one authorization application, in one place and the answer to this application will be final and binding in every member of the EU. Every data collected in the studies will be gathered in one European universal database and it will be freely available.

This article means to describe briefly the reasons and the goals behind this regulation and the new royal decree, and also some of the innovation nationwide.


Clinical Trials European Union Pharmaceuticals Regulation



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