The main outcomes of the 3rd Public Meeting of The National Health Surveillance Agency (ANVISA’s) Board of Directors in 2026, focusing on new resolutions for foreign trade, pharmaceutical standards, regulatory projects, and the agency’s operational capacity.
This document covers the following information:
- Approval of a new resolution updating administrative procedures for foreign trade operations, with emphasis on stricter controls for sensitive substances and products
- Amendment of RDC 977/2025 to enhance monitoring and inspection of controlled substances and imported pharmaceutical and biological products
- Ratification of a Normative Instruction to update the List of Reference Drugs (MRL), establishing benchmarks for efficacy, safety, and quality required for generic and similar drug registration
- Extension of the public consultation period regarding procedures for ANVISA’s inspection actions
- Extension of deadlines for the preliminary analysis phase in the Pilot Project of the Experimental Regulatory Environment (Regulatory Sandbox) focused on personal care products, cosmetics, and personalized perfumes
- Recognition of the appointment of new civil servants and the new chief prosecutor, expanding the agency’s operational and legal capacity
- Updates on ANVISA’s recent international missions to India and South Korea, aimed at strengthening technical cooperation and regulatory bridges
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