ANVISA is Brazil's national health surveillance authority. Its pharmacovigilance portal consolidates legislation, reporting-system information, benefit-risk reporting resources, alerts and safety communications.
Core official resources
- ANVISA Pharmacovigilance — central pharmacovigilance hub, including VigiMed, alerts, bulletins and periodic benefit-risk reporting resources.
- Legislation applied to pharmacovigilance — official access point for RDC 406/2020, IN 63/2020 and ANVISA questions-and-answers material.
- ANVISA — regulator portal for current regulatory publications and notices.
Practical use
RDC 406/2020 addresses good pharmacovigilance practices for holders of human-medicine registrations, while IN 63/2020 addresses the Relatório Periódico de Avaliação BenefÃcio-Risco (RPBR). Check the current consolidated texts and ANVISA updates before operational implementation.