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institutionsInstitution
Agência Nacional de Vigilância Sanitária
ANVISA registers medicines in Brazil, Latin America's largest market, and joined the FDA's Project Orbis in 2019; public coverage is decided separately by CONITEC, so the gap between ANVISA registration and availability in the public system is a central issue in Brazilian oncology.
Also called: ANVISABrazilian Health Regulatory Agency
Overview
Created in 1999, ANVISA regulates medicines, devices, food, cosmetics and tobacco in Brazil and registers new drugs before they can be sold or considered for the public health system. It joined the FDA's Project Orbis in 2019, has adopted reliance and priority review pathways for oncology drugs, and is an ICH member. Coverage in the public Sistema Único de Saúde is decided separately by CONITEC, which conducts health technology assessment, while private insurers follow the ANS list; the gap between ANVISA registration and public availability is a central issue in Brazilian oncology. ANVISA's tobacco regulation includes some of the world's earliest bans on flavoured cigarettes.
Location
Brasília, BR
Type
government
Website
Newsweek 2026 oncology rank
Not in top 300 listing used
OnCo score
#564 · 4 points (0 Newsweek + 0 NCI + 4 from 2 linked objects) · ranking
- Drug registration and priority review
- Project Orbis participation
- ICH membership and reliance pathways
- Tobacco regulation
Leandro Pinheiro Safatle
Diretor-Presidente (Director-President) of Anvisa
Health regulationMedicines regulationPublic health policy
Director-President of Anvisa, the Brazilian health regulatory agency that authorises medicines, including cancer treatments, for the Brazilian market.
Carlos Barrios
Medical oncologist; Director, Oncology Research Center, Hospital São Lucas PUCRS; Latin American Cooperative Oncology Group
Breast cancerClinical trials in Latin AmericaGlobal oncology
Carlos Barrios is the most visible Latin American voice in global breast cancer trials and a founder of the region's cooperative group LACOG.
Paulo Hoff
Medical oncologist; gastrointestinal oncology; Brazilian oncology leadership (Sírio-Libanês, USP, Oncologia D'Or)
Colorectal cancerGastrointestinal oncologyClinical trials
Brazil's most prominent GI oncologist, a former MD Anderson faculty member who built oncology programmes at Sírio-Libanês and ICESP.
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