Open Audiências Públicas (Public Hearings)
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Audiências Públicas (public hearings) are a mandatory step in ANVISA's regulatory process for significant new regulations. They allow stakeholders to present oral comments and questions to ANVISA's technical team and collegiate board — more interactive than a written consultation alone.
Current open audiências públicas
Check ANVISA's website for currently scheduled audiências públicas:
Participating effectively
Preparation:
- Register early — spaces for oral presentations are limited.
- Review the draft regulation thoroughly before the hearing.
- Prepare clear, concise oral comments (typically 5–10 minutes per participant).
- Focus on specific articles or technical issues, not general positions.
After the hearing:
- ANVISA publishes transcripts or summaries of audiências públicas.
- ANVISA's response to comments is published as part of the final regulation's explanatory note (nota de rodapé or análise de impacto regulatório).
Industry associations (ABIMO, SBCTA) often coordinate collective responses to audiências públicas — consider engaging through your industry association.
Official sources
Verify all information against official ANVISA sources before making regulatory decisions.