Brasília – The National Health Surveillance Agency (ANVISA) expands its backlog reduction initiative for biologic products to include post-registration petitions related to safety and efficacy, broadening the scope of its optimized review framework. The measure builds on recent regulatory changes aimed at accelerating technical assessments while maintaining quality and safety standards.

The initiative introduces a dedicated optimized review queue and applies criteria established under Collegiate Board Resolution (RDC) 997/2025 and Normative Instruction 289/2024, including the grouping of similar dossiers and enhanced interaction with companies to streamline evaluations. ANVISA states that the expansion improves transparency, predictability, and efficiency in regulatory processes, reinforcing efforts to reduce backlogs and speed up access to biologic therapies in Brazil.

Source: ANVISA