Brazil: ANVISA Publishes New Clinical Trial Guidance Documents and Transitions to New Website

On September 29, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) website migrated to the following new URL: https://www.gov.br/anvisa. For more details regarding the migration, please see this notice.

On September 11, 2020, ANVISA published two (2) inspection guides on Good Clinical Practices (GCPs) for clinical trials for medicines and biological products. Guide No. 35 focuses on inspection of Clinical Trial Centers and Guide No. 36 focuses on inspection of sponsors and representative clinical research organizations. Both of these guides aim to harmonize and guide those involved in inspection procedures, ensuring a unified standard and the safety of all involved parties. For more details, see this notice. (Google translation of Guide No. 35) (Google translation of Guide No. 36)

On July 15, 2020, ANVISA released Service Orientation 88/2020, which provides details on document analysis procedures required for submission of the Clinical Drug Development Dossier (DDCM) and changes that potentially impact the quality or safety of experimental drugs, active comparators, or placebos. For more details, see this notice. (Google translation of Service Orientation 88/2020)

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