Audiências Públicas — Public Consultations
BR-unique
Audiências Públicas and Consultas Públicas are ANVISA's formal mechanisms for consulting with industry, healthcare professionals, patients and the public before issuing new regulations. All significant new ANVISA regulations — including RDCs — must go through a public consultation process before being finalised.
Types of consultation
| Type | Description |
|---|---|
| Consulta Pública (CP) | Written consultation — stakeholders submit written comments within a defined period (typically 30–60 days) |
| Audiência Pública | Public hearing — oral presentations and discussions, often combined with a written consultation |
How to participate
- Monitor ANVISA's website for open consultations at gov.br/anvisa/pt-br/assuntos/regulamentacao.
- Download the draft regulation and/or consultation document.
- Submit written comments via the ANVISA portal within the consultation period.
- For audiências públicas: register to attend or present (registration details published on ANVISA's website).
ANVISA publishes a summary of responses and its reasoning for accepting or rejecting comments after each consultation — these are valuable for understanding ANVISA's thinking on specific regulatory issues.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.