The National Health Surveillance Agency ANVISA (ANVISA) in the Resolution (RDC) No. 9 to the official gazette of Brazil published new rules pertaining to clinical research for medical devices and drugs. Industry experts opined that the new regulations will have a positive impact and are hopeful that they will bring sharpness and transparency into the clinical research process standards, thereby reducing the bureaucracy. Further, the resolution reflects that ANVISA is heading towards harmonization of the clinical research process to the international measures. New rules will lead to a quick and effective clinical research performance in Brazil, which was not possible earlier. Now, ANVISA will have to follow a deadline to approve the completion of research process. The new rules are likely to attract foreign investments in Brazilian clinical researches especially phase III studies, since the country has a diverse population base to demonstrate safety and efficacy.
