[Sanitary regulation as part of health policy in Brazil: gaps and challenges].

Objective To outline and discuss the main challenges for sanitary regulation contained in the federal-level Brazilian health policy. Methods For the present qualitative study, based on the analysis of public policies, information was collected from documents and interviews. Document analysis provided a historical overview of the insertion of sanitary regulation into the Brazilian health policy between 1999 and 2009 (first decade of existence of the national health surveillance agency, Anvisa). In addition, 13 interviews were carried out with actors selected for their historical, technical, or academic role in the field. Content analysis was used to define themes emerging from the materials analyzed with a focus on the "content" category, which refers to strategic and operational guidelines of policy programs, projects, initiatives, and normative framework. Results Content analysis revealed five themes that reflect the challenges to sanitary regulation in Brazil: 1) objects under regulation treated as isolated cases; 2) a Brazilian-specific model of sanitary regulation that is different from other international models; 3) ignorance regarding the role of sanitary surveillance in health care; 4) absence of an information system; and 5) absence of performance indicators and assessment tools. Conclusions Sanitary surveillance must have a mission that is disentangled from inspection tasks to become an effective instrument of health protection. For that, an information system that brings the National Sanitary Surveillance System together toward major objectives is essential. The adoption of tools for assessment of action is also required, with the establishment of adequate indicators.