Brazil Profile Updated with Extended Validity Dates for Certain ANVISA Regulations

June 2, 2023

The Brazil profile in ClinRegs has been updated to include extended validity dates for National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) regulations related to the review and submission of clinical trial applications that were enacted during the COVID-19 public health emergency. (See Scope of Assessment and Timeline of Review)

Sources Added During this Update:

(Regulation) Resolution of the Collegiate Board of Directors – RDC No. 790 of May 15, 2023 (ResNo790 – Portuguese) (Effective May 22, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board of Directors – RDC No. 791 of May 15, 2023 (ResNo791 – Portuguese) (Effective May 22, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health

(Regulation) Resolution of the Collegiate Board of Directors – RDC No. 799 of May 19, 2023 (ResNo799 – Portuguese) (Effective May 22, 2023)
National Health Surveillance Agency (ANVISA), Ministry of Health