Brazil: New Bioanalytical Standard Published

| 24 May 2012 |  By 

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

More Breaking News from RegLink


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy