Alignment between sanitary regulation and drug policies in Brazil

• Autor(a) principal: Taveira, Rodrigo Abrão Veloso
• Data de Publicação: 2015
• Outros Autores: Naves, Janeth de Oliveira Silva
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/233
• topic: National Health Surveillance Agency; Legislation; Drug; National Drug Policy; National Policy of Pharmaceutical Assistance; Agência Nacional de Vigilância Sanitária; Legislação de Medicamentos; Política Nacional de Medicamentos; Política Nacional de Assistência Farmacêutica

Objectives: Assess the production of Anvisa´s regulations regarding medications and check your alignment to the National Drug Policy and the National Policy of Pharmaceutical Assistance. Methods: This is a descriptive study, the type of data collection, based on quantitative research method and also using elements of documentary research. We used the resolutions of Anvisa published in the period 1999-2012. These resolutions were divided into “normative” and “non-normative” and grouped into twelve themes. For the resolutions related to the theme drugs were defined categories, according to the main subject regulated. At the end, we analyzed the correlation between these resolutions and the directives established by National Drug Policy and strategic priorities of the National Policy of Pharmaceutical Assistance, characterizing the alignment between the regulatory process and public policy. Results: Were identified 2367 resolutions, whereas 43% are “normative”. The remaining (57%) were not considered in the analysis. The main theme  regulated by Anvisa  was drugs (37%), followed by food (22%) and sanitizing (7%). All resolutions normative related to drugs are aligned to at least one directive of the National Drug Policy and one strategic priority of the National Policy of Pharmaceutical Assistance. Conclusions: The main conclusion of the research, which has an unpublished character, is the fact that the regulatory action of Anvisa related to drugs is aligned to the main steering instruments of Brazilian federal government in this sector. Thus, it can be stated that the Agency has contributed to the implementation of the policies studied, providing important subsidies for the maintenance of safety, efficacy and quality of medicines and pharmaceutical services available to the population.