This Wednesday, April 15, during the 6^th Public Meeting of its Collegiate Board, the Brazilian FDA (Anvisa) presented an action plan aimed at reducing the backlog of drug marketing approval applications under review in Brazil. The initiative seeks to tackle one of the Agency’s main institutional challenges for 2026: the high volume of pending regulatory demands.

The plan’s primary goal is not only to cut down the number of pending petitions but also to drive structural gains in efficiency, predictability, and quality in regulatory operations, aiming to expand public access to safe, effective, and high-quality medications. To this end, the strategy combines structural and operational measures organized into integrated focus areas, which include reducing the backlog of regulatory petitions, decreasing review times, mitigating delays associated with meeting technical requirements, and strengthening cross-cutting actions related to process management, human resources, and technological infrastructure.

The proposal builds on initiatives already well established at Anvisa, such as streamlined reviews, reliance mechanisms — which allow leveraging evaluations conducted by other regulatory authorities — and grouped reviews of technically similar applications. At the same time, it introduces new measures to modernize workflows. Key highlights in this regard include the internal reorganization of processes based on continuous indicator monitoring and active risk management, as well as expanded models of interaction with the regulated sector to reduce rework and increase review efficiency.

The plan also includes the revision of regulatory acts and the enhancement of instruments that encourage the use of optimized review pathways. In parallel, Anvisa stresses the importance of the quality of submissions made by companies and the timely fulfillment of technical requirements, both considered essential for smooth process flow.

Among the initiatives, the “Missão Registro” (“Mission Registration”) project stands out. It promotes institutional mobilization to accelerate case reviews, encouraging direct involvement of the Agency’s technical experts in reducing the petition backlog.

Anvisa noted that, although the plan has been well received by the regulated sector, challenges regarding adherence to the proposed strategies remain, especially for initiatives that require greater engagement from companies. In this context, the Agency emphasizes the need for collaborative action, recognizing that the effectiveness of the measures is directly tied to the quality of the information submitted and the active participation of regulated entities.

With the plan’s implementation, Anvisa expects a consistent reduction in the regulatory backlog, shorter review times, increased technical team productivity, and strengthened predictability and transparency in the regulatory process. Additionally, the initiative seeks to ensure the sustainability of results through structural changes capable of achieving a lasting balance between growing regulatory demand and the Agency’s operational capacity.

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