Brazilian regulations modelled on the FDA
As in other countries, pharmaceuticals in Brazil have to meet strict regulatory requirements. ANVISA, Brazil’s National Health Surveillance Agency, created in 1999, has modelled its operations on the FDA. It is tasked with reviewing drug marketing authorization applications and monitoring patent enforcement. Linked to the Ministry of Health, ANVISA is financially autonomous and managed by an independent Board of Directors. In addition to reviewing registration applications, the agency’s duties include conducting health inspections on health care product manufacturing plants and processes, issuing or withdrawing Good Manufacturing Practices certificates, and setting up and coordinating toxicological & pharmaceutical surveillance systems, etc. ANVISA is also responsible for monitoring, regulating and inspecting products which pose public health risks.