Brazil

Pharmacovigilance in Brazil is regulated by the Brazilian Health Regulatory Agency (ANVISA). The current framework is based on RDC No. 406/2020 and IN No. 63/2020, with RDC No. 406/2020 amended by RDC No. 967/2025. From 21 March 2026, the amendment makes WHODrug coding mandatory for company reports in VigiMed Empresas and replaces E2B(R2) with ICH E2B(R3). Drug Registration Holders (DRMs) must operate a pharmacovigilance system with the required responsible-person and safety-reporting arrangements. Serious adverse events occurring in Brazil that meet the regulatory reporting criteria must be submitted through VigiMed within 15 calendar days. DRMs must prepare Periodic Benefit-Risk Assessment Reports (RPBRs) and submit or retain them according to ANVISA's current RPBR rules and active-substance schedule. ANVISA also conducts pharmacovigilance inspections under the national framework. Brazilian requirements should use local RDC/IN terminology rather than assume an EU-style QPPV or PSMF model. BAUPHARMA supporting resources (operational context only, not national regulatory evidence): How to Prepare and Comply with a Pharmacovigilance Inspection.