Brazil: ANVISA Issues Updated Guidelines Related to COVID-19 and Clinical Trials

On July 28, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued an updated technical note providing guidance to sponsors, centers, and researchers related to clinical research and COVID-19.

The note provides additional information related to the following: training for telemedicine visits; remote assessment of outcomes; removal of requirement to document the agreement of the parties in case of remote verification of source documents; updates to specific requirements related to COVID-19 studies; and updates related to the collection and evaluation of biological materials for bioequivalence studies. (Google translation of technical note)

For details on all of Brazil's clinical research regulatory requirements, view the Brazil country profile.