Anvisa (Agência Nacional de Vigilância Sanitária), officially the National Health Surveillance Agency, is Brazil’s federal authority for health surveillance. Established in 1999 and linked to the Ministry of Health, it operates as an autonomous regulator to protect public health by ensuring the safety, efficacy, and quality of products and services subject to sanitary control.
The agency regulates and authorizes medicines, vaccines, biopharmaceuticals, active pharmaceutical ingredients (APIs), medical devices, foods, cosmetics, and sanitizing products, among others. It conducts Good Manufacturing Practice (GMP) inspections and certifications in Brazil and abroad for sites that supply the Brazilian market, grants marketing authorizations, and oversees clinical research approvals where applicable. Anvisa also runs post-market surveillance programs, including pharmacovigilance and materiovigilance, and enforces compliance through inspections at ports, airports, and borders.
For the chemical and life sciences sectors, Anvisa sets technical standards, evaluates quality and safety dossiers, assesses toxicological risks (including for certain pesticides and controlled substances within its remit), and collaborates internationally to align with recognized regulatory practices. Its decisions shape market access and quality benchmarks across Brazil’s healthcare and related industries.
