South Africa Profile Updated

April 26, 2023
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The South Africa profile in ClinRegs has been updated to include the following information:

  • South African Health Products Regulatory Authority (SAHPRA) Clinical Trials Committee meeting and application submission dates for 2023 (See Scope of Assessment, Submission Process, and Timeline of Review)
  • Additional information about SAHPRA’s responsibilities (See Regulatory Authority)
  • Additional information on submitting proof of application delivery and payment to SAHPRA (See Submission Process)
  • Updated versions of several SAHPRA guidelines and the safety reporting form that were revised in Fall 2022 with administrative and formatting changes. These revisions did not impact ClinRegs summary content.

Sources Added During this Update:

(Document) 2020/21 – 2024/25 Strategic Plan (ZAF-9) (January 2022)
South African Health Products Regulatory Authority

(Webpage) FAQs – Clinical Trials (ZAF-1) (Current as of April 25, 2023)
South African Health Products Regulatory Authority

Sources Revised During this Update:

(Guidance) Capacity Building and Transformation in Clinical Research in South Africa (G-Capacity) (Version 2) (October 2022)
South African Health Products Regulatory Authority

(Guidance) Clinical Trial Investigators (G-CTInvestigators) (Version 3) (Effective October 24, 2022)
South African Health Products Regulatory Authority

(Guidance) General Information (G-GenInfo) (Version 11) (April 17, 2023)
South African Health Products Regulatory Authority

(Guidance) SA Guide to Good Manufacturing Practice for Medicines (SA-GMPs) (Version 8) (September 18, 2022)
South African Health Products Regulatory Authority

(Guidance) Safety Reporting During Clinical Trials in South Africa (G-SafetyRpt) (Version 5) (October 2022)
South African Health Products Regulatory Authority

(Document) Clinical Trials Committee Meeting and Submission Dates for 2023 (ZAF-11) (Version 1) (October 26, 2022)
South African Health Products Regulatory Authority

(Form) Safety Reporting During Clinical Trials Form (ZAF-19) (Version 4) (Effective October 26, 2022)
South African Health Products Regulatory Authority

(Webpage) Clinical Trials (ZAF-36) (Current as of April 25, 2023)
South African Health Products Regulatory Authority

(Webpage) South African Health Products Regulatory Authority - About Us (ZAF-39) (Current as of April 25, 2023)
South African Health Products Regulatory Authority

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