Brazil: ANVISA and CONEP Issue Updated Requirements Related to COVID-19 and Clinical Research

December 22, 2020

On December 17, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued RDC nº 449 of 12/15/2020, which amends Articles 38 and 71 of ResolutionNo9 of February 20, 2015. Article 38 now allows for the sponsor to provide proof of clinical trial registration when submitting the clinical trial start date form if it is not available at the time of clinical trial application submission. Article 71 allows for ANVISA’s temporary and emergency use of remote Good Clinical Practice (GCP) monitoring in place of in-person inspection. (Google translation of RDC nº 449 of 12/15/2020)

On November 3, 2020, Brazil’s National Research Ethics Commission (Comissão Nacional de Ética em Pesquisa (CONEP)), issued a communication to research ethics committees outlining which COVID-19 related research protocols should be reviewed by ethics committees and which should be forwarded to CONEP for expedited review. In particular, the following types of research protocols should be sent to CONEP: clinical trials; protocols in special thematic areas; protocols specified by the Ministry of Health, by the health secretaries of the States, Municipalities, and the Federal District; and other protocols at the discretion of the ethics committee. (Google translation of Communication)

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