ANVISA
Brazil's federal health surveillance agency that regulates clinical trials, medicines, medical devices, and cosmetics.
What it means
ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil's federal health surveillance agency. It reviews clinical trial protocols, product registration dossiers, and post-market changes for medicines, medical devices, biologics, and cosmetics. Every submission to ANVISA must be in Brazilian Portuguese.
Why it matters for LATAM submissions
Brazil is the largest clinical trial market in Latin America. ANVISA's review timeline can be shortened when translations match its controlled vocabulary and formatting expectations from the first cycle.
Relevant regulators
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