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Brazil: ANVISA Publishes Guidance on Procedure for Biological Analysis

Wednesday, February 28, 2018: The Brazilian National Health Surveillance Agency (ANVISA) publishes new guidance on the procedures for analyzing applications for registration and post-registration of biological products within the scope of the General Management of Medicines and Biological Products (GGMED).

In accordance with the provisions of resolutions RDC 55/10 and RDC 49/11, two analytical procedures have been established and should be followed by the Biological Product Evaluation Office (GPBIO) when analyzing registration and post registration applications of organic products: detailed procedure and optimized procedure. The criteria to be fulfilled for each procedure are determined in the order of Service 45/2018. In addition, clarification note 2/2018 was also prepared, which provides further clarification as to the content of OS 45/2018.

The service orientation is an initiative of the GPBIO / GGMED to improve the time of analysis of petitions related to biological products, aiming at meeting the deadlines stipulated by Law 13.411 / 16.

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