Brazil’s Anvisa produces new committee for the accelerated submission of COVID-19 related clinical trials.
Anvisa has established a Committee for Evaluation of Clinical Studies, Registration and Post-registration of Drugs for prevention or treatment of Covid-19.
Brazil’s Anvisa publishes Service Orientation (OS) that may provide simplification of clinical trial applications (DDCM)
Anvisa pusblishes Service Orientation (OS) 88/2020 provides details on procedures for reviewing documents required for submission of the Clinical Drug Development Dossier (DDCM) and changes that potentially impact the quality or safety of experimental drugs, active BE drugs or placebos.