ANVISA: Expands Recognition of Foreign GMP Authorities
Brazilian health authority ANVISA has updated the requirements for the recognition of Equivalent Foreign Regulatory Authorities (AREE) and the administrative procedures for Good Manufacturing Practice (GMP) certification (CBPF) through Normative Instruction IN 451/2026. The aim is to streamline and accelerate regulatory processes.
A key change is the expansion of the list of recognised foreign authorities. In the future, Anvisa will also recognise decentralised or regional regulatory authorities. The newly recognised authorities originate from Germany, Spain, Switzerland and Japan, allowing Anvisa to rely on GMP inspection reports issued by these authorities within optimised certification procedures.
In addition, the administrative process for submitting foreign inspection reports has been revised. Relevant documentation must now be submitted as an amendment to an existing CBPF application. According to Anvisa, this change will improve traceability and increase regulatory efficiency.
Source:
ANVISA: Anvisa atualiza Instrução Normativa e orienta sobre novo fluxo para CBPF
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