Brasília – Anvisa has officially published RDC No. 997/2025 and Ordinance No. 1.385/2025, confirming the exceptional and temporary measures approved by the Collegiate Board to reduce the regulatory backlog and normalize review timelines for drug registrations, post-approval changes, biologics, and clinical trial authorizations.

The new framework introduces optimized analysis queues, reliance-based procedures, dossier clustering, exceptional PGAs, reprioritization mechanisms, and targeted fast-track pathways. Combined, these elements mark a structural shift in Anvisa’s operational model — with greater emphasis on efficiency, transparency, and predictability.

Beyond the RDC, the creation of the Regulatory Innovation Committee establishes a permanent governance structure to monitor high-impact technologies, support regulatory coordination, and accelerate scientific and technical decision-making for products of strategic public-health relevance.

To support companies, investors, and policymakers, PharmaBR has prepared a comprehensive technical report covering:

• Interpretation of RDC No. 997/2025
• Detailed breakdown of the new exceptional procedures
• Implications for clinical research, synthetic drugs, biologics and CADIFA
• Expected operational impacts for 2025–2026
• Key insights from Anvisa’s Collegiate Board meeting and directors’ statements
• Analysis of Ordinance No. 1.385/2025 and the new Innovation Committee

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