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ANVISA tackles 24-month backlog in biologicals post-registration petitions

Home/Policies & Legislation | Posted 10/10/2025 0

In a bid to accelerate the review of post-approval changes for biological products, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) has launched an enhanced phase of its Optimized Online Analysis Project. Managed by the Biological Products Evaluation Team (GPBIO), the initiative targets a significant reduction in the current 24-month backlog for post-registration petitions.

Early success with faster processing
Though still in its initial stages, the project has already shown promising results. As of June 2025, 56 petitions have been finalized – a 27% increase over the monthly average since the beginning of the year. Among the latest approvals are those listed in Resolution RE 2,021 (29 May 2025), published on 2 June 2025. ANVISA aims to sustain this accelerated pace in the coming months.

Task force to tackle pending petitions
To further streamline reviews, ANVISA has assembled a dedicated task force focusing on petitions submitted before 28 February 2025, which are still awaiting evaluation under the standard process. The team employs an agile workflow, including virtual meetings between ANVISA’s technical staff and industry representatives.

Industry collaboration key to success
ANVISA has emphasized that active participation from companies is critical to the project’s effectiveness. The agency urges firms to ensure their technical teams are responsive to task force inquiries to avoid delays.

Director’s statement: a priority for regulatory efficiency
ANVISA Director Daniel Pereira highlighted the agency’s commitment to faster approvals: ‘Reducing backlogs is a top priority. This project proves that with strategic planning, focus, and industry collaboration, we can deliver rapid results. This isn’t an isolated effort—it’s part of broader reforms to enhance predictability and speed in regulatory reviews.’

Alignment with recent regulatory reforms
The initiative complements recent updates to Brazil’s post-approval framework, including RDC 876/2024, which amended RDC 413/2020 to simplify submissions and optimize lifecycle management for biological products [1].

Public consultation for the modification of the biosimilars regulation in Brazil

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. Regulatory update for post-registration of biological products in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Oct 10]. Available from: www.gabionline.net/guidelines/regulatory-update-for-post-registration-of-biological-products-in-brazil

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