Anvisa Updates BA, BE Test Best Practices Certification
Posted 10 October 2014 | By
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
Brazilian regulator Anvisa has released an updated Certification of Good Practice for the conduct of bioavailability/bioequivalence (BA/BE) studies.
The practices are those that must be adopted by research centers in order to ensure their BA/BE studies—comparing pharmacokinetic and pharmacodynamics parameters between a test product and its reference drug or comparator—are conducted correctly and to Brazilian regulatory standards.
One of the changes on the new certification is the validity period, which was changed to two years from the expiration of the previous certificate. BA/BE for registration and post-registration of medicines are also required to be performed in certified test centers.