Brazil’s Anvisa 2025 announcement introduces structural and immediate measures to reduce approval queues for medicines, medical devices, and clinical trials. Backlogs caused by staff shortages, outdated systems, and increasing product complexity have delayed regulatory approvals. To address this, Anvisa will strengthen its workforce, improve working conditions, modernize systems via the AnvisAI project, and implement temporary measures—including task forces, dedicated clinical trial queues, and risk-based inspections—until 2026, ensuring faster access to innovative healthcare products.
Diagnosis of Current Challenges
- Staff reductions (30% over 2014–2024) and budget constraints limited modernization.
- Increasing technological complexity and growth in applications caused longer approval queues.
- Delays affected registration, post-registration, clinical trials, and inspections.
Structural Measures by Anvisa
- Hiring 102 new health regulation specialists in Q1 2026.
- Improved work conditions and performance management initiatives.
- Modernization through AnvisAI, investing R$25 million in AI for faster, more accurate reviews.
- Implementation of eCTD electronic submissions and petitioning system upgrades.
- Establishment of Regulatory Monitoring Committee for Innovation in Health.
Temporary and Exceptional Measures (Valid Until 2026)
- Clinical trials: Dedicated queue and reliance on international regulatory data.
- Medicines: Grouped analysis of synthetic, biological medicines by active ingredients or company; prioritize low-risk processes.
- Medical devices: Task force for temporary workforce reallocation; automated approvals for lower-risk devices.
- Inspections: Risk-based model focusing on higher-risk cases while simplifying low-risk inspections.
Expected Impact
- Reduction of queue liabilities for medicines, biologics, and medical devices.
- Faster review and approval times for healthcare products.
- Improved efficiency, predictability, and access for innovative treatments.
- Monitoring committee ensures continuous evaluation, transparency, and social participation.
Key Takeaways for Manufacturers
- Prepare to submit applications efficiently using new AI-supported processes.
- Monitor queue progress and take advantage of risk-based prioritization.
- Collaborate with Anvisa through reliance and grouped submissions where applicable.
Internal Links
- Learn about our newly launched AI builder currently operational for Brazil ANVISA notifications and registrations
External Links
