[Drug regulatory authorities in South America: an analysis based on organizational rules]. / Autoridades reguladoras de medicamentos sul-americanas: uma análise a partir de regras organizacionais.
Rev Panam Salud Publica
; 34(3): 169-75, 2013 Sep.
Article
em Pt
| MEDLINE
| ID: mdl-24233109
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.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Controle de Medicamentos e Entorpecentes
Tipo de estudo:
Prognostic_studies
País/Região como assunto:
America do sul
Idioma:
Pt
Revista:
Rev Panam Salud Publica
Assunto da revista:
SAUDE PUBLICA
Ano de publicação:
2013
Tipo de documento:
Article
País de afiliação:
Brasil
País de publicação:
Estados Unidos