Measures cover drug registration, clinical trials, and expanded cooperation with international regulators
On November 7, 2025, the Board of Directors of the Brazilian Health Regulatory Agency (Anvisa) approved a comprehensive package of structural and exceptional measures designed to address the Agency’s longstanding review backlog and enhance the overall efficiency and predictability of its regulatory decisions.
For years, Anvisa has faced rising regulatory demand amid shrinking staff levels and outdated information systems, resulting in longer processing times for drug and post-approval submissions. Between 2014 and 2024, the Agency’s workforce declined by roughly 30%, directly affecting operational capacity and review timelines.
Measures To Boost Regulatory Efficiency
The newly approved initiatives seek to expedite regulatory assessments and clear accumulated backlogs in the areas of clinical trials, pharmaceuticals, and biological products. These measures will be implemented through upcoming Board Resolutions (RDCs).
a) Streamlined Queue Management
At the core of the package is a new approach to managing Anvisa’s review queues. The current “first-in, first-out” model has proven inadequate in handling the volume and technical complexity of submissions, leading to limited predictability and delayed access to new therapies. The reforms introduce a more flexible, risk-based, and efficiency-oriented system.
Key actions include:
- Dedicated reliance queues. Applications submitted under the reliance pathway will be reviewed in separate, prioritized queues with clear selection criteria. For drugs, for example, this approach could cut total review time by up to 45%, leveraging assessments previously conducted by trusted foreign regulators.
- Exceptional Evaluation Management Plans (PGAs). The draft resolution allows the grouping of technically similar dossiers – such as those sharing the same active pharmaceutical ingredient (API) or dosage form – for joint and harmonized assessment. This is expected to yield efficiency gains of up to 20% and ensure more consistent regulatory outcomes.
- Replacement of pending applications. Companies may withdraw and replace unreviewed submissions within the same priority category, enabling Anvisa to focus resources on active and commercially relevant applications.
- Early risk classification. Following the model introduced by RDC No. 823/2023, the new rule permits early application of risk classifications to identified pending issues, prioritizing low-risk cases and reducing unnecessary regulatory exchanges.
All changes in queue order or prioritization will be disclosed on Anvisa’s website, including the rationale and expected impact of each measure, ensuring transparency and external oversight.
b) International Cooperation and Reliance Expansion
The Board also approved updates to Anvisa Normative Instruction No. 289/2024, expanding the scope of the reliance framework and the list of Equivalent Foreign Regulatory Authorities (AREEs) recognized by the Agency. The move aims to enhance the use of foreign assessment reports and accelerate the approval of innovative products.
The revised rule shall:
- Add Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) as a recognized authority for medicines, biologics, and vaccines;
- Extend the recognition of the European Medicines Agency (EMA) and Health Canada to include assessments of active pharmaceutical ingredients (APIs).
Monitoring And Transparency
Anvisa will establish a Queue Reduction Monitoring Committee to oversee implementation, track performance indicators, and publish transparency reports. The Agency expects to normalize review timelines within 12 months, improving efficiency, predictability, and timely access to health technologies.
For regulated companies, the initiative offers a more predictable regulatory environment, new management tools for submission strategies, and greater clarity around review priorities for clinical trial approvals and product registration processes.
Organizations are advised to closely follow the publication of the final resolutions and operational notices, which will set out detailed procedures for eligibility, timelines, and classification criteria.