Brazil Update: New Pharmacopeial Methods, Microbiology Testing Standards

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Anvisa Proposes Alternative Pharmacopeial Methods

Brazil’s national regulatory agency, Anvisa, is inviting comments on proposed alternative Pharmacopeial microbiological methods that can be used to replace those currently listed in the Brazilian Pharmacopoeia, with faster and better results. 

The proposal complements the framework of documents that are part of the Brazilian Pharmacopoeia, which are important for the domestic production of medicines. The consultation officially opened on 11 July 2014 and will remain open for 30 days.

Anvisa Proposes Certification Procedures for Bioequivalence Research Centers

Brazil’s national regulatory agency, Anvisa, has opened a consultation on a proposed standard for the certification of research centers in Brazil that conduct bioequivalence and bioavailability studies needed for drug registration in Brazil.

The proposed standard would update the existing regulations that mandate the minimum criteria for these studies and for accreditation of the research centers that conduct them. According to Anvisa, the proposed changes to the existing standards are needed to bring Brazil’s regulatory requirements in line with international guidelines that incorporate technical and scientific progress in the field of bioequivalence and bioavailability testing.