New subject codes for filing applications for GMP certification for biological products industries

Last Friday, September 9th, the Brazilian FDA (ANVISA) published and made available new subject codes for submitting requests related to the Good Manufacturing Practices certifications – GMP (“BPF” in Portuguese) for biological products industries.

Formerly, the protocol was carried out under subject codes related to Medicines – Sterile Products. In such scenario, the Brazilian FDA faced difficulties in monitoring the processes, and the procedures were more complex.

According to the Agency, the applicant is not required to make any changes to the petitions that have already been filed, as they will be regularly analyzed by the responsible department.

Find below the list of new subjects that must be used for new requests:

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