Abstract

PEREZ MACHIN, Maykel  and  ARABETTI, Celso. Regulations issued in the Republic of Argentina for conducting clinical trials on drugs. Rev Cubana Salud Pública [online]. 2010, vol.36, n.2, pp.185-189. ISSN 0864-3466.

The Good Clinical Practice Guideline emerged in 1996 in the International Conference on Harmonization that provides a unified standard for the European Union, Japan and the United States about the methodology to be used in clinical pharmacological studies with drugs. It facilitates the mutual acceptance of collected data and also lays down that these studies should be conducted in conformity with the Declaration of Helsinki. Within the clinical pharmacological research, the National Administration of Drug, Food and Medical Technology of the Republic of Argentina has recently enacted several regulations regarding the performance of clinical assays in the country. Despite this unified Good Clinical Practice guideline, there are several local restrictions in the regulatory setting in Argentina, so being aware of the normative framework of that country is of vital importance to establish cooperation ties between the various pharmaceutical industries and to obtain health registration in the different countries. This article offers an updating on the main regulations of the Argentine regulatory body to conduct clinical assays with drugs.

Keywords : Clinical assays; drugs; regulations.

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