ANVISA published RDC nº 997/2025, establishing exceptional and temporary measures aimed at improving the efficiency of regulatory review queues for clinical trial authorizations, marketing authorization applications (MA), and post-approval submissions related to medicines and biological products.
The new framework aligns with Brazil’s broader reliance strategy, as defined under RDC 945/2024 and IN 289/2024, allowing the creation of optimized analysis queues and more flexible mechanisms for managing ongoing submissions. The resolution enables companies to reorganize their applications by formally withdrawing and resubmitting processes in order to benefit from the new prioritization logic.
Key Highlights
- Exceptional and Temporary Measures (RDC 997/2025)
Establishes a temporary regulatory framework to optimize review queues for clinical trials, marketing authorization, and post-approval submissions involving medicines and biological products. - Optimized and Reliance-Aligned Queues
Creates optimized analysis queues aligned with Brazil’s reliance framework, improving processing efficiency and regulatory predictability. - Queue Reorganization Mechanism
Allows companies to reorganize submissions within the same corporate group through formal withdrawal and re-entry of applications to access the new prioritization logic. - Exceptional Assessment Management Plan (PGA Excepcional)
Introduces the PGA Excepcional as a strategic tool to reduce regulatory backlog and enable prioritization beyond strict chronological order. - Operational Impact
Applies to clinical trials, marketing authorization applications, and post-approval submissions, supporting faster decision-making and more predictable review timelines.
This update reinforces ANVISA’s ongoing efforts to reduce regulatory backlog, enhance reliance-based approaches, and improve efficiency and predictability across regulatory review processes for medicinal and biological products.
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