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  • Brazil: New Bioanalytical Standard Published

    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 exist...