Brazil’s ANVISA opens public consultation on bioavailability/bioequivalence of medicines
The Brazilian National Health Surveillance Agency, ANVISA, has initiated a public consultation to review the RDC 103/2003. The regulation establishes the procedures and requirements for the certification of research centers conducting bioavailability and bioequivalence studies for the purpose of registration of pharmaceutical drugs in Brazil, reports Juliane Carvalho of Brazil Pharma News.
There are two resolutions in place dealing with the subject: Resolution RDC 41 of April 28, 2000, which establishes the minimum criteria for acceptance of research centers performing these clinical studies and the RDC No 103 of May 8 of 2003 containing the procedures and criteria for accreditation of research centers performing bioavailability/bioequivalence studies.
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