The 3rd Public Meeting of the Dicol in 2026 reaffirmed ANVISA’s trajectory towards a more transparent and digital regulatory environment. Among the session’s milestones, the approval of the update to sanitary control in foreign trade operations and the refinement of the List of Reference Medicines (LMR) stand out, in addition to adjustments to innovation project schedules.

Below, we detail the main points discussed and their impact on the regulated sector.

1. The New Foreign Trade Scenario: RDC No. 977/2025

The approval of the update to RDC No. 977/2025 represents a fundamental step towards simplifying international logistics operations. This regulation, which acts as the new framework for sanitary control in foreign trade, has broadened the Agency’s scope of action by including the monitoring of export operations and integrating processes with the Federal Revenue Service through the Single Window for Foreign Trade (Pucomex) and the Single Import Declaration (DUIMP).

In practice, RDC 977/2025 aims to reduce bureaucracy and operational costs, allowing for the early registration of goods and the adoption of remote and scheduled inspections. In addition, the regulation improves the monitoring of controlled substances and prioritizes clearance in cases of shortages of essential medicines.

2. List of Reference Medicines (LMR): The Pillar of Equivalence

The updating of the List of Reference Medicines (LMR), formalized via Normative Instruction, is an essential continuous procedure for the stability of the pharmaceutical market. Reference medicines are innovative products whose efficacy, safety, and quality have been scientifically proven to the Agency.

Its practical function is to serve as the standard of comparison (bioequivalence and pharmaceutical equivalence) for the marketing authorization of generic and similar (branded generic) medicinal products in Brazil. Keeping this list updated ensures that new technologies incorporated into the market can serve as a basis for expanding access to safe and interchangeable treatments.

The update was subsequently published in the form of IN 428/2026.

3. Social Participation and Inspection Procedures

The Board ratified the 30-day extension of the Public Consultation (PC) on the definition of procedures for inspection actions. Public consultation is the mechanism that allows the regulated sector and civil society to submit critical evaluations and substantiated suggestions on draft regulations.

In this specific case, the PC seeks to regulate the Sanitary Administrative Process (SAP) from the perspective of responsive inspection, which considers the compliance history of companies and the proportionality of sanctions, ensuring due process and the right to a fair hearing.

4. Innovation and the Regulatory Sandbox for Personalized Cosmetics

Another highlight was the extension of the deadline for the preliminary results of the Regulatory Sandbox Pilot Project focused on personalized cosmetics. The Sandbox is an experimental regulatory environment that allows companies to test innovative technologies and production models (real-time customization) under the supervision of ANVISA.

The objective of this project is to generate technical evidence for the creation of definitive regulations that guarantee the safety, efficacy, and traceability of personalized hygiene and perfume products, fostering responsible innovation in the HPPC sector.

5. Institutional Vision and Governance

During the meeting, the Board also celebrated the expansion of the Agency’s operational capacity with the appointment of new staff members to the position of Specialist in Regulation and Sanitary Surveillance and welcomed the new chief prosecutor, Dr. Flávia Oliveira Tavares. Agency’s president, Leandro Safatle, also reinforced Brazil’s strong international presence — evidenced by recent missions to South Korea and India — and we will have a post on our blog talking about that.