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Regulatory Focus™ > News Articles > Brazil Updates Criteria for Drug Registration

Brazil Updates Criteria for Drug Registration

Posted 22 January 2013 | By Louise Zornoza

Brazil's national regulatory authority, Anvisa, has opened a Public Consultation on proposed revisions to the criteria for the technical requirements for quality, safety and efficacy needed to support the registration of new, generic and biosimilar medicines.

The consultation, released on 8 January 2013, would replace Resolutions RDC No. 136/2003, RDC No. 16/2007 and RDC No. 17/2007, whose update was prompted by new technological developments.

The deadline for comments on the consultation is 5 April 2013.

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