[Drug regulatory authorities in South America: an analysis based on organizational rules].
OBJECTIVE
To describe the organization of national drug regulatory authorities (DRAs) in Argentina, Brazil, Chile, and Peru through the analysis of categories representing organizational rules.


METHODS
The DRAs were selected using the following criteria: being in a South American country, having been identified as DRAs at Encuentros de Autoridades Competentes en Medicamentos de los Países Iberoamericanos (Conferences of Ibero-American Drug Regulatory Authorities), and having good availability of electronic data regarding organizational structure and the process of drug regulation. The main source of data were websites, which were reviewed between May 2010 and March 2011. The analytical categories were: organizational structure, competencies, directionality (mission and vision statements), and forms of accountability.


RESULTS
The DRAs of Argentina and Brazil functioned as autonomous agencies, while those of Chile and Peru were directly subordinated to the ministries of health. Except for the Brazilian DRA, the agencies in the other three countries were dependent on their health ministries to issue sanitary regulations. The scope of action of each DRA differed in terms of the goods and services covered, with the Peruvian DRA being the only one exclusively dedicated to the regulation of drugs. The four DRAs performed all the processes identified by the World Health Organization as essential for effective drug regulation.


CONCLUSIONS
The results show an effort by the studied countries to improve their regulatory structure. Nevertheless, all four DRAs need to improve some mechanisms to ensure that, at the end of the regulatory chain, the drugs they regulate have the desired quality and safety, with more transparency in decision-making processes and social accountability.
Escola Nacional de Saúde Pública Sérgio Arouca, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brasil.
Mariane Martins da Silva
MM
Sandri
Marismary Horsth
MH
De Seta
Vera Lucia
VL
Luiza
D003906:Developing Countries; D017277:Drug Approval / Q000458:organization & administration; D004346:Drug Information Services / Q000458:organization & administration; D004335:Drug and Narcotic Control / Q000458:organization & administration*; D006077:Government Agencies / Q000458:organization & administration; D007880:Legislation, Drug; D012941:Social Responsibility; D013020:South America; D014944:World Health Organization