Brazil: ANVISA Issues Notice on Safety Reporting and COVID-19 Clinical Trials

On February 11, 2021, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued a notice stating that, due to some instabilities with the online NotivsaEC form, sponsors must also email notifications of unexpected serious adverse events (SAEs) to notivisa.pesquisa@anvisa.gov.br. The title of the email must state, “EVENTO ADVERSO GRAVE INESPERADO_[name of the medication].” The email must include a spreadsheet containing all of the information included in the NotivisaEC form.

For COVID-19 studies, the title of the email must state, “EVENTO ADVERSO GRAVE INESPERADO__[name of the medication]_COVID-19.” The notice also provides specific details for sponsors regarding the requirement to register in the VigiMed system, Brazil’s new adverse event reporting system. Regarding the migration to this new system, ANVISA is starting with the registration of sponsors conducting COVID-19 clinical trials.

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