Brazil Profile Updated in ClinRegs

April 29, 2020
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The Brazil profile in ClinRegs has been reviewed and updated to reflect current requirements and information including:

  • Information on the National Health Surveillance Agency’s (Agência Nacional de Vigilância Sanitária (ANVISA)) new technical review procedures for clinical trial applications containing at least one phase III clinical trial protocol (See Scope of Assessment, Submission Process, and Submission Content)
  • Information on ANVISA’s clinical trial application authorization timelines (See Timeline of Review)
  • Amended sponsor requirements guaranteeing participants access to the post-study drug program, even when the study is terminated early (See Compensation)
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