This paper discusses the Brazilian experience of health regulation from 1999 to 2008. It aims to understand the interfaces of the regulatory process in health in Brazil, particularly the pharmaceutical industry, seeking to identify, historically, the actors and contexts relating to the proceedings. The research was based on literature review and survey of the resolutions of the Board of the National Health Surveillance Agency. This survey identified the concentration of these resolutions in the following areas: drugs, human resources and food. Regarding drugs, emphasis was placed in three key words: drug registration, practices and substances subject to special control. In addition to a brief history of the evolution of Brazilian health surveillance, this paper focused on the regulatory aspects of the National Health Surveillance Agency and its relationship with the pharmaceutical industry. Therefore, the text was guided by the desire to answer the following question: is the experience of regulation of the National Health Surveillance Agency able to cope with the adverse scenario created by the world crisis, especially with regard to the pharmaceutical industry? The main conclusion of this study is that despite the many challenges to be overcome by the National Sanitary Surveillance Agency in Brazil today, the experience of regulation has made good progress in this decade. A further finding is that these developments were, for the pharmaceutical industry, a protection against the adverse situation created by the global crisis.
health; regulation; National Health Surveillance Agency; health surveillance; pharmaceutical care; Brazil