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Brazil’s National Health Surveillance Agency (Anvisa) published Ordinance No. 1,423/2025 in the Official Gazette on November 21, 2025, establishing a Committee for Monitoring and Evaluating the Action Plan for Backlog Management. The committee will initially operate for 12 months, extendable for an additional 6 months upon decision by its members. Its role is to systematically monitor actions aimed at reducing regulatory backlogs and improving review timelines for petitions, covering all products and services subject to health surveillance, as provided under Article 8, §1 of Law No. 9,782/1999.

The measure, stemming from Topic No. 4.2 of Anvisa’s 2024/2025 Regulatory Schedule, reflects the agency’s effort to address a structural issue affecting the effectiveness of the health regulatory system: the inability to process, within a reasonable timeframe, the growing volume of submitted petitions. While the initiative responds to demands for greater regulatory predictability, it also highlights longstanding weaknesses in backlog management.

The committee includes representatives from Anvisa’s five directorates and allows, depending on the agenda, participation from regulated sector entities, formalizing a dialogue channel between the agency and stakeholders. However, the creation of a temporary committee raises questions about whether this approach is sufficient to address a problem rooted not only in monitoring deficiencies but also in structural challenges – such as understaffing of specialized personnel, the technical complexity of regulated products, and the accumulation of regulatory obligations that are not periodically reviewed. In this sense, the committee may be seen as a short-term, mitigating measure whose effectiveness will depend on broader actions beyond the scope of the ordinance itself.

Some measures are already underway. On November 7, 2025, Anvisa’s Board announced structural and emergency initiatives to optimize backlog management, including workforce reinforcement, technological innovation (such as AI), and procedural adjustments. Although the agency’s goal is to sort out the backlog issue within one year, achieving this will require coordinated implementation and deeper reforms. While initiatives such as reliance mechanisms, task forces, grouped reviews, and automation may provide short-term relief, they do not fully address underlying bottlenecks related to technical complexity, regulatory overload, and lack of long-term planning.

Despite representing progress, the ordinance would benefit from the establishment of binding parameters for the committee’s activities, such as clear targets, accountability mechanisms, and transparency rules – especially in a context of increasing judicialization.

For regulated entities, the ordinance may serve as a relevant—though not guaranteed—tool to mitigate regulatory risks. The (conditional) opening for private sector input creates opportunities to identify technical bottlenecks, highlight procedural shortcomings, and challenge unclear prioritization criteria, particularly in areas with which Anvisa itself acknowledges that it has been struggling, such as high-complexity medical devices, advanced therapies, and the assessment of new technologies.

In summary, Ordinance No. 1,423/2025 represents another step in addressing longstanding challenges in regulatory backlog management. However, it lacks sufficient institutional depth to drive transformative change. Its success will depend on integration with broader measures, including regulatory framework review, strengthening of technical capacity, system modernization, and stabilization of internal workflows. Without such reforms, the ordinance is likely to function as a complementary tool within a system that still requires significant improvements to ensure legal certainty, administrative efficiency, predictability, and adequate health protection in the face of modern regulatory challenges.