Brazil: ANVISA Issues Notice for Clinical Trials Impacted by COVID-19

April 2, 2020

On March 23, 2020, the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued a technical note providing guidance to sponsors, centers, and researchers on the conduct of clinical research and bioequivalence studies that may be impacted by COVID-19. (Google translation of technical note)

As previously noted, in February 2020, Brazil’s National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)) issued a requirement that all COVID-19 research protocols must go to CONEP for expedited review. This requirement will continue as long as the World Health Organization (WHO) designates COVID-19 as a global public health emergency. (Google translation of requirement)