The RAPS learning platform provider will be upgrading its security posture. This will take the system off-line from 20 July through the end of the day 23 July. This will affect any Online Course, eBook, and Virtual Program Attendance. Thank you for your patience.
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
More Breaking News from RegLink
Regulatory Focus newsletters
All the biggest regulatory news and happenings.
Subscribe
