South Africa Profile Updated in ClinRegs

November 5, 2021
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The South Africa profile in ClinRegs has been reviewed and updated to include the following:

  • The 3rd edition of the South African Good Clinical Practice: Clinical Trial Guidelines
  • Updated safety reporting timeframes, including for foreign reports of safety issues in multi-country trials (See Safety Reporting section)

Sources Added During this Update:

  • (Webpage) Pan African Clinical Trials Registry (ZAF-50) (Current as of November 3, 2021)
    Pan African Clinical Trials Registry

Sources Revised During this Update:

  • (Guidance) South African Good Clinical Practice: Clinical Trial Guidelines (SA-GCPs) (3rd edition) (2020)
    National Department of Health
  • (Guidance) Safety Reporting During Clinical Trials in South Africa (G-SafetyRpt) (Version 4) (August 2021)
    South African Health Products Regulatory Authority
  • (Document) Clinical Trials Committee Meeting and Submission Dates for 2022 (ZAF-11) (Date Unavailable)
    South African Health Products Regulatory Authority
  • (Form) Notification Studies Template: Phase IV (ZAF-17) (Version 3) (April 2020)
    South African Health Products Regulatory Authority
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