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Regulatory Focus™ > News Articles > Brazil: New Bioanalytical Standard Published

Brazil: New Bioanalytical Standard Published

Posted 24 May 2012 | By Louise Zornoza

Brazil's national regulatory agency, Anvisa, has published a new standard (RDC 27/2012) setting forth the minimum requirements for conducting the bioanalytical method validation studies needed for the registration of medicines.

The new requirements take effect as of 1 December 2012 and will replace several provisions of Resolution 899/2003 on bioanalytical methods. 

Industry may file documentation with Anvisa in accordance with the old standard or use the existing standard until 1 December 2012.

Read more:

RDC 27/2012

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