Brazil Updates
Brazil Profile Updated
Aug 9, 2023 - The Brazil profile in ClinRegs has been updated to remove Resolution of the Collegiate Board - RDC No. 534 of August 23, 2021 and the related Resolution of the Collegiate Board of Directors – RDC No. 799 of May 19, 2023, which extended the validity of RDC No. 534 until July 20, 2023.
Brazil Profile Updated with Extended Validity Dates for Certain ANVISA Regulations
Jun 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 ...
Brazil Profile Updated
Apr 12, 2023 - The Brazil profile in ClinRegs has been reviewed and updated with the following information:
National Health Council (Conselho Nacional de Saúde (CNS)) regulation from 2022 providing review criteria and timelines to classify research and process protocols in the institutional ethics ...
Brazil Profile Updated with Amendment to Rare Diseases Resolution
Dec 13, 2022 - The Brazil profile in ClinRegs has been updated to include RDC No. 763, of November 25, 2022, which amends RDC No. 205, of December 28, 2017. A pre-submission meeting related to an application to conduct a clinical trial of a rare disease is now only required if deemed necessary by the applicant. ...
Brazil Profile Updated with New Expiration Date for Public Health Emergency Requirements and Clarifications to Safety Reporting Requirements
Aug 16, 2022 - The Brazil profile in ClinRegs was updated with the following information:
Inclusion of Ordinance No. 913, which declared an end to Brazil’s public health emergency related to COVID-19 as of May 22, 2022 (See Scope of Assessment and Timeline of Review)
Inclusion of Resolution No. 683, ...
Brazil Profile Updated
May 12, 2022 - Brazil Profile Updated
The Brazil profile in ClinRegs has been reviewed and updated with the following information:
New regulation amending investigational product import procedures (See Manufacturing & Import and Specimen Import & Export)
New regulation on Certification ...
Brazil Profile Updated
Dec 8, 2021 - The Brazil profile in ClinRegs has been updated with the following information:
RDC No. 573 of October 29, 2021, which changes, on an emergency and temporary basis, RDC No. 9 of February 20, 2015, which approves the regulation for conducting clinical trials with medicines in Brazil (See ...
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