Brasília – Anvisa’s General Management of Medicines (GGMED) adopted a new set of operational procedures to implement RDC 997/2025, the rule that creates exceptional and temporary mechanisms to reduce Brazil’s regulatory backlog for medicines and biologics. The measure reorganizes Anvisa’s internal workflow, establishing a more granular and predictable analysis structure for companies awaiting regulatory decisions.

Under the new framework, GGMED creates five dedicated sub-queues within the Optimized Analysis Procedure, separating petitions into specific technical categories: active-substance dossiers (CADIFA), bioequivalence studies, quality documentation, impurity qualification, and safety-and-efficacy evaluation. The aim is to improve prioritization, allocate specialized teams more efficiently, and ensure that complex dossiers do not delay the review of simpler or well-structured submissions.

The rule also formalizes the possibility of substituting a petition’s position in the queue through a controlled withdrawal and resubmission mechanism, allowing companies to replace stalled or outdated dossiers without losing their place in line. According to Anvisa, the adjustments are part of a broader effort to modernize regulatory operations and accelerate access to safe and effective medicines in Brazil.

Source: Anvisa

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