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.

The need to review the current regulation is due to technical and scientific progress in the field of bioequivalence and bioavailability of pharmaceutical drugs in recent years, with the upgrade of national and international guidelines for regulation, inspection centers and evaluation of these clinical studies. The participation in the public consultation is open to anyone. The electronic form is available on the ANVISA site.