On June 15, 2026, the Brazilian health authority ANVISA published Regulatory Instruction No. 451, which updates the criteria for the recognition of equivalent foreign regulatory authorities (AREEs) and reorganizes the administrative procedures for obtaining the certification of good manufacturing practices (CBPF). The changes introduced aim to ensure increased transparency and to facilitate and accelerate regulatory processes.
Among the main changes introduced, the most significant is the formal recognition of the decentralized regulatory authorities of countries with decentralized regulatory models, such as Germany, Spain, Switzerland, and Japan. The amendment introduced by IN 451/2026 allows ANVISA to make use of the inspection reports drawn up by the competent regional bodies, as they are recognized as having the same level of reliability as those issued by the corresponding central regulatory authority.
Another significant change concerns the reorganization of the AREEs classification system, which now provides for the standardization of procedures for the designation and exclusion of authorities recognized by ANVISA.
Overall, the optimization of the document analysis flow should be more streamlined and transparent, enhancing the traceability of information and making the procedure more in line with the operational reality of the certification processes.
SOURCE:
Anvisa atualiza Instrução Normativa e orienta sobre novo fluxo para CBPF