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 December 1, 2012, and will replace in part the 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 December 1, 2012.