Brazil Anvisa Regulatory Agenda 2026–2027

Brazil’s National Health Surveillance Agency (Anvisa) approved the Brazil Anvisa Regulatory Agenda 2026–2027, defining the regulatory priorities that will guide health surveillance activities over the next two years. The agenda highlights 161 priority topics and provides greater transparency and predictability for companies navigating Brazil’s regulatory landscape.

What Is the Anvisa Regulatory Agenda 2026–2027?

The Anvisa Regulatory Agenda is a strategic planning instrument that outlines the regulations Anvisa intends to develop, revise, or review within a defined period. The 2026–2027 agenda serves as a public roadmap, helping stakeholders anticipate upcoming regulatory changes across all areas under Anvisa’s authority, including medicines, medical devices, food, cosmetics, and health services.

By publishing this agenda in advance, Anvisa strengthens regulatory governance and enables earlier stakeholder engagement.

Key Highlights of the 2026–2027 Agenda

• 161 priority regulatory topics identified for the two-year cycle

• Coverage across all health surveillance sectors regulated by Anvisa

• Focus on regulatory improvement, modernization, and public health protection

• Clear visibility into future rulemaking and regulatory reviews

Not all agenda items will necessarily result in new regulations, but each topic represents an area where regulatory action or assessment is expected.

How the Agenda Was Developed

The Brazil Anvisa Regulatory Agenda 2026–2027 was built through a structured and participatory process:

1. Proposals were submitted by Anvisa’s internal technical teams

2. Topics were opened for public consultation, allowing input from citizens, companies, and organizations

3. Contributions were reviewed and consolidated

4. The final agenda received approval from Anvisa’s Collegiate Board

This approach ensures that regulatory priorities reflect both technical expertise and societal needs.

Impact on Industry and Compliance Planning

For regulated companies, the agenda is a valuable planning tool. It allows manufacturers, distributors, and service providers to:

• Anticipate regulatory changes and timelines

• Align internal compliance strategies with Anvisa’s priorities

• Prepare for future updates affecting product approvals and post-market obligations

• Monitor areas where new guidance or regulatory revisions may emerge

Early awareness can significantly reduce regulatory risk and improve market access strategies in Brazil.

Next Steps for Stakeholders

Companies operating in Brazil should closely monitor agenda items relevant to their products or services and be prepared to participate in future consultations. Continuous engagement with Anvisa’s regulatory planning helps ensure smoother compliance and timely adaptation to new requirements.

For the official announcement and full list of priority topics, refer to Anvisa’s website:
Anvisa aprova Agenda Regulatória 2026–2027 — Agência Nacional de Vigilância Sanitária (Anvisa)  

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