Regulatory Focus™ > News Articles > Brazil Suspends Certification Process for Foreign Bioequivalence and Bioavailability Test Centers

Brazil Suspends Certification Process for Foreign Bioequivalence and Bioavailability Test Centers

Posted 05 August 2013 | By Louise Zornoza 

Brazil's National Agency for Sanitary Surveillance (Anvisa) has suspended processing of new applications for primary certification of bioavailability or bioequivalence for medical products by research centers located outside the country.

Applications filed prior to 31 July 2013, the date the suspension entered into force (RDC 37/13), will still be processed, regulators said.

The purpose of the suspension is to facilitate the review of existing rules governing foreign centers and the development of a new certification model that will be implemented later. The new certification model is being prepared now by the agency and will be released for public consultation after review and approval of the Board of Anvisa.


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