Agência Nacional de Vigilância Sanitária
Brazilian regulator; issues GMP under RDC resolutions and is an ICH member.
WHAT ANVISA COVERS
The Agência Nacional de Vigilância Sanitária regulates medicines, devices, food, cosmetics, and sanitary matters across Brazil, the largest pharmaceutical market in Latin America. Its requirements are issued as Collegiate Board Resolutions (RDCs), with RDC 658/2022 providing the general GMP framework for medicines.
WHERE IT SITS INTERNATIONALLY
ANVISA became a PIC/S participating authority in 2021 and joined ICH as a member in 2016 — the two moves that drove its convergence with international GMP.
HOW ITS REQUIREMENTS BITE
ANVISA certifies GMP compliance following inspection, and a valid GMP certificate is a prerequisite for product registration — so quality compliance is directly coupled to market access. It inspects both domestic sites and foreign manufacturers supplying Brazil, though PIC/S membership has opened reliance routes that reduce duplicate inspection.
WHAT ANVISA PUBLISHES
- 01RDC 658/2022 — general GMP for medicines (replacing RDC 301/2019)
- 02Complementary and product-specific RDCs (sterile products, APIs, and others)
- 03Brazilian Pharmacopoeia (Farmacopeia Brasileira)
- 04GMP certificates and inspection outcomes
- 05Normative Instructions (INs) carrying technical detail under an RDC
WHAT PRACTITIONERS GET WRONG
- ›RDC 658/2022 is harmonised with PIC/S, so an EU- or PIC/S-compliant site is largely aligned on technical substance.
- ›A valid GMP certificate is a registration prerequisite — plan the certification lead time into launch schedules rather than treating it as a closing formality.
- ›Portuguese-language documentation expectations are real and routinely underestimated by sponsors used to English-only dossiers.
- ›Check whether a complementary RDC applies to your product type; the general framework is not the whole picture, and sterile products and APIs carry their own resolutions.
- ›Brazil is the largest market in the region, so its requirements often set the practical bar for a Latin American supply strategy.
ANVISA STANDARDS SPEQ DECODES · 1
DISCIPLINES IN ANVISA’S REMIT
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