Recently, the Brazilian National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária) known as ANVISA shared an updated technical note, offering new guidance to biopharmaceutical sponsors, research centers and clinical investigators in relation to clinical research and the unfolding COVID-19 pandemic.
Given the intensity of the virus’ spread throughout Brazil ANVISA needed to act to ensure the continuity of the critically important clinical research sector. The ANVISA updates, reports ClinRegs, a valuable offering made available by National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), centers on 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
· Updates related to the collection and evaluation of biological materials for bioequivalence studies