Brazilian Health Regulatory Agency (ANVISA) has released Technical Note (NT) 51/2025, introducing crucial updates to the procedural guidelines for the registration and post-registration of biological products in Brazil. This new note complements and updates NT 134/2024, aiming to enhance the transparency, predictability, and efficiency of regulatory assessments conducted by the General Management of Biological Products (GGBIO).
Key Updates in Note 51/2025
1. New Subject Codes for Petition Protocols: ANVISA introduced several new subject codes to better categorize biological products. These now include:
- Biotechnologicals (e.g., code 12370),
- Other Biomedicines (e.g., code 12368),
- Allergenic Products (code 12371),
- Probiotics (code 12372),
- And a dedicated code for Covid-19 vaccine composition updates (code 12374), aligned with RDC 905 and IN 316/2024.
These changes align with RDC 55/2010, which defines classifications within registration of biological products.
2. End of Manual Protocols: According to RDC 947/2024, manual petition protocols are being phased out—only exceptions involving CTD (Common Technical Document) formats remain. The electronic process is now prioritized, improving traceability and reducing administrative costs. However, manual protocols are temporarily permitted until April 30, 2025, to ease the transition.
3. Simultaneous Post-Registration Changes: Following RDC 913/2024, companies can now consolidate certain simultaneous post-registration changes into a single petition, provided they meet specific criteria—e.g., related changes supported by the same documentation or linked to a primary change. This streamlined approach minimizes redundancy and accelerates processing.
4. Conditional Approvals via Optimized Procedure: Under IN 289/2024, ANVISA now allows conditional approvals for quality-related post-registration changes based on foreign regulatory authority evaluations (AREE). This marks a significant shift toward international regulatory harmonization and faster approvals.
Benefits for the Pharmaceutical Sector
These updated guidelines offer multiple benefits:
- Greater clarity for applicants,
- Faster processing of petitions,
- Reduced duplication of efforts through grouped protocols,
- Alignment with global standards, especially for vaccines and biosimilars,
- Minimized delays through conditional approvals.
Companies that follow these procedures can expect reduced rework and more predictable timelines, ultimately supporting faster market access and regulatory compliance.
For further details, refer to the full document here.