February 16, 2026
Brazil’s health regulatory authority ANVISA has officially released its Regulatory Agenda 2026–2027, establishing the Agency’s priority regulatory actions for the next two years. Approved by ANVISA’s Collegiate Board (Dicol), the agenda includes 161 priority regulatory topics, combining legacy items, periodic regulatory reviews, and new themes arising from technical risk analysis, public consultation, and data-driven regulatory governance.
For global manufacturers, exporters, and regulatory affairs teams, this agenda serves as a forward-looking compliance roadmap that directly impacts market authorization strategy, lifecycle management, risk management, and post-market surveillance in Brazil.
Why the ANVISA Regulatory Agenda Matters
The Regulatory Agenda is not just a planning document it is a regulatory intelligence tool that signals:
- Upcoming rulemaking and technical updates
- Shift in compliance expectations
- Areas of increased regulatory scrutiny
- Emerging public health priorities
- Opportunities for stakeholder engagement
Core Regulatory Focus Areas (2026–2027)
| Sector | Regulatory Emphasis | Compliance Impact |
| Medicines | GMP modernization, pharmacovigilance updates, dossier lifecycle management | Stronger post-market oversight |
| Medical Devices | Risk classification, software & digital health regulation, cybersecurity | Expanded documentation & TPLC control |
| Food & Nutrition | Safety standards, contaminants, labeling harmonization | Reformulation & labeling reviews |
| Cross-Sector Topics | Regulatory digitalization, transparency, inspection modernization | Electronic submissions & data traceability |
Regulatory Governance & Transparency Enhancements
ANVISA is reinforcing:
- Structured public consultation processes
- Evidence-based rulemaking
- Digital regulatory tracking systems
- Performance monitoring dashboards
This aligns Brazil with global regulatory convergence trends seen in the FDA, EMA, and Health Canada.
Strategic Implications for Industry
Organizations operating in Brazil should:
1. Strengthen Regulatory Intelligence
Monitor ANVISA consultations, technical notes, and RDC updates.
2. Update Compliance Frameworks
Ensure QMS, PMS, labeling, and technical documentation reflect anticipated changes.
3. Align Product Development with Regulatory Trends
Early incorporation of evolving standards reduces rework and approval delays.
4. Prepare for Digital Submissions
Brazil continues moving toward electronic regulatory systems and structured data formats.
Emerging 2026 Regulatory Themes
- Risk-based regulation
- Lifecycle approach to product oversight
- Digital health governance
- Data integrity & traceability
- Regulatory harmonization initiatives
- AI/Software in medical devices
- Strengthened inspection frameworks
How Maven Regulatory Solutions Supports ANVISA Compliance
Maven Regulatory Solutions provides:
- Brazil market entry strategy
- ANVISA dossier preparation & gap analysis
- Regulatory intelligence monitoring
- Lifecycle management planning
- Pharmacovigilance & post-market strategy
- Device registration & classification support
- Food compliance advisory
FAQ
What is ANVISA’s Regulatory Agenda?
A two-year priority framework guiding Brazilian regulatory updates.
Who is impacted?
Pharma, biotech, MedTech, food manufacturers, and global exporters.
Why is early preparation critical?
To avoid delays, non-compliance findings, and reformulation risks.
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