Brazil Updates
Brazil: ANVISA Issues Service Bulletin on Expedited Clinical Trial Review
Jul 12, 2021 - The Brazil profile in ClinRegs has been updated to include Service Bulletin No. 104 - Document Analysis Procedures Required for DDCM Petitions and for Protocol Modifications that Potentially Impact Experimental Drug, Active Comparator or Placebo Quality/Safety, which ...
Brazil: ANVISA Issues Notice on Safety Reporting and COVID-19 Clinical Trials
Feb 18, 2021 - 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 ...
Brazil: ANVISA and CONEP Issue Updated Requirements Related to COVID-19 and Clinical Research
Dec 22, 2020 - On December 17, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued RDC nº 449 of 12/15/2020, which amends Articles 38 and 71 of ResolutionNo9 of February 20, 2015. Article 38 now allows for the sponsor to provide ...
Brazil: ANVISA Publishes New Clinical Trial Guidance Documents and Transitions to New Website
Oct 2, 2020 - 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, ...
Brazil: ANVISA Issues Updated Guidelines Related to COVID-19 and Clinical Trials
Aug 4, 2020 - On July 28, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued an updated technical note providing guidance to sponsors, centers, and researchers related to clinical research and COVID-19.
The ...
Brazil: ANVISA Issues Updated Guidelines Related to COVID-19 and Clinical Trials
Jun 25, 2020 - On June 15, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued an updated technical note providing guidance to sponsors, centers, and researchers related to clinical research and COVID-19. The note ...
Brazil: ANVISA and CONEP Issue Updated Requirements Related to COVID-19 and Clinical Trials
May 5, 2020 - On April 22, 2020, Brazil’s National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária (ANVISA)) issued an updated technical note providing guidance to sponsors, centers, and researchers related to clinical research and COVID-19. The note ...
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