According to the General Management of Sanitary Inspection and Supervision (GGFIS), the changes incorporated by IN #451/2026 stem from the experience gained in the application of IN #292/2024 and seek to provide greater transparency, predictability and flexibility to the Reliance mechanism adopted by the Agency, in addition to expanding its
use in the certification processes conducted by the area.

Among the main changes introduced by the rule, the most notable is the explicit recognition of decentralized regulatory authorities in countries with decentralized regulatory models, such as Germany, Spain, Switzerland, and Japan. With the amendment introduced by IN #451/2026, inspection reports issued by legally competent regional bodies are now
formally recognized at the same level of trust attributed to the corresponding central regulatory authority.

Another relevant change concerns the reorganization of the classification system for AREEs. The rule provides for the standardization of procedures for the designation and exclusion of authorities recognized by ANVISA, as well as the reorganization of the regulation’s annexes in accordance with the various levels of regulatory trust. Annex I will now include authorities classified as having partial or full trust, while Annex II will be reserved for authorities subject to mutual recognition agreements. The Agency clarified that, currently, there are no authorities that fall into this last category.

The proposal also includes updating the list of recognized authorities, with the addition of the Jordan Food and Drug Administration — the regulatory authority of Jordan — among the eligible authorities, at a partial or full regulatory trust level, for the purposes of sanitary inspection and Good Manufacturing Practices certification.

According to ANVISA, the amendment seeks to eliminate procedural obstacles observed in practice, reduce rework, and prevent companies from losing their place in the analysis queue due to the need for separate processing of documentation, thereby ensuring greater procedural efficiency.

The redesign of the workflow also tends to reduce the risk of rejections based solely on formal filling issues. According to the Agency Directors, integrating the documentation into the main process strengthens the traceability of information, increases regulatory predictability, and makes the procedure more aligned with the operational reality of certification
processes.

During the discussion of the topic, the members of the Board of Directors emphasized that the changes do not alter the regulatory foundations of the Reliance model already adopted by ANVISA, but seek to improve its implementation and expand the use of information produced by recognized foreign regulatory authorities, while fully preserving the Agency’s technical and decision-making autonomy.

The Agency expects that the measures will help reduce duplicate inspections, optimize inspection resources, and decrease administrative rework, with potential positive effects on the analysis deadlines for drug and biological product registrations that depend on the issuance of these certificates.

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