2025-09-01 Reference source : ANVISA
Latin America Regulatory Updates Brazil Anvisa
Brazil’s National Health Surveillance Agency (Anvisa) has begun preparing its new Regulatory Agenda for 2026–2027, a process that will run until December this year in line with the country’s legal and management framework. The agenda, which sets out the agency’s regulatory priorities for the next two years, must be published by 17 December. It is part of Anvisa’s Annual Management Plan and is required under Law No. 13.848/2019.
Public Participation Opens
Anvisa is currently in the stage of public engagement. Between 15 August and 15 September, citizens, civil society groups, and members of the National Health Surveillance System (SNVS) are invited to provide feedback on the preliminary list of regulatory themes. Contributions can be made through an online form.
Alongside commenting on the proposed topics, participants will also be able to suggest new items if they believe important regulatory issues are missing.
Preliminary List of Themes
The draft agenda features 115 regulatory themes, of which 97 were carried over from the 2024–2025 agenda and 18 are new proposals from Anvisa’s technical departments.
The agency has published the preliminary list in two formats – a summary in PDF and a detailed spreadsheet – to facilitate public review, and can be found here (in Portughese).
Next Steps
Anvisa stresses that this consultation is a fact-finding stage and not the final list of priorities. The inputs collected will inform the final version of the Regulatory Agenda 2026–2027, which will be formally approved by Anvisa’s Collegiate Board later this year. A manual on how to participate to the consultation can be found here (in Portughese).
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