A Agência Nacional de Vigilância Sanitária e Política Nacional de Medicamentos: um estudo da regulação sanitária de medicamentos no Brasil, com base nas Resoluções da diretoria Colegiada da Anvisa, entre 1999 e 2013.

Abstract

The study analyzes the sanitary regulation of medicines in Brazil, in the years 1999 to 2013, carried out by the Brazilian Health Surveillance Agency (Anvisa). Therefore, the resolutions of the Board of Directors were used (RDC s), from the perspective of documentary analysis. The resolutions express the decisions of that board for regulatory purposes or intervention and are strategic for the sanitary regulation exerted by Anvisa, because from them the agency informs the Brazilian society (the general population, Ministry of Health, industrial health complex economic and industry pharmaceutical) on decisions taken within the sanitary regulation. The objective is to analyze, based on RDC s issued by Anvisa between 1999 and 2013, the role of the agency in the National Drug Policy. From a methodological standpoint, the study is based on analysis of official document and has exploratory character. The main conclusion is that the agency operating in the sanitary regulation of medicines approached the guidelines of the National Drugs Policy. Thus, despite the challenges of health regulation process for the area of drugs, 15 years of creation of Anvisa were decisive for the implementation of this policy.