Agência Nacional de Vigilância Sanitária
Brazil's medicines regulator, a Project Orbis partner, and the gatekeeper for cancer drug approval in Latin America's largest market.
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.
- Drug registration and priority review
- Project Orbis participation
- ICH membership and reliance pathways
- Tobacco regulation
Carlos Barrios is the most visible Latin American voice in global breast cancer trials and a founder of the region's cooperative group LACOG.
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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not linked directly; found by shared links- IdeaBurden-matched funding for trials led in low- and middle-income countries
Shares Hospital Israelita Albert Einstein, Carlos Barrios, Most of the world has almost no cancer care.
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- InstitutionPharmaceuticals and Medical Devices Agency
Shares FDA Oncology Center of Excellence, Regulatory divergence between regions, Most of the world has almost no cancer care.
- IdeaFund an oncology joint assessment unit inside the African Medicines Agency
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- Idea90-day reliance approval for cancer drugs cleared by two stringent regulators
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- IdeaPivotal trials include sites in Africa, South Asia and Latin America, sponsor-funded
Shares Carlos Barrios, Most of the world has almost no cancer care.
- IdeaLive tracker of the lag from first approval to real availability in every country
Shares Regulatory divergence between regions, Most of the world has almost no cancer care.
- InstitutionCentral Drugs Standard Control Organization
Shares FDA Oncology Center of Excellence, Most of the world has almost no cancer care.