Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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
Tags: Bioanalytic, Standard, pharmaceutical, brazil, drug
Regulatory Focus newsletters
All the biggest regulatory news and happenings.