South Africa Profile Updated

September 26, 2022
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The South Africa profile in ClinRegs has been reviewed for accuracy and updated with the following information:

  • Updated SAHPRA contact information (See Regulatory Authority)
  • Updated application to conduct a clinical trial and updated application for a protocol amendment to an approved clinical trial (See Submission Process and Submission Content)
  • Ethics committee (EC) guidance related to the National Health Research Ethics Council (NHREC), the application to register an EC, and the annual report form for ECs registered with the NHREC (See Authorizing Body)
  • Updated guidance on electronic submission of clinical trial documents (See Submission Process and Safety Reporting)
  • New guidance on how to apply for a license to manufacture, import, and/or export investigational products (See Manufacturing & Import)
  • Updated information on supplementary documents to be included with an application for a license to manufacture or import an investigational product (See Manufacturing & Import)
  • Updated SAHPRA compensation guidance (See Compensation)

Sources Added During this Update:

(Guidance) Guideline for Release of Import Health Products at Ports of Entry (G-ImprtPorts) (Version 2) (June 2022)
South African Health Products Regulatory Authority

(Guidance) Guideline on How to Apply for a License to Manufacture, Import, and/or Export Medicines and Scheduled Substances (G-ManuImpExp) (Version 3) (June 2022)
South African Health Products Regulatory Authority

(Form) Annual Report Form for Human Research Ethics Committees Registered with the National Health Research Ethics Council (ZAF-54) (Version 2.21) (May 13, 2021)
National Health Research Ethics Council

(Form) Application to Register a Human Research Ethics Committee (ZAF-53) (Version 2.21) (May 13, 2021)
National Health Research Ethics Council

(Form) License Application to Manufacture, Import, or Export (HCR) Medicines and Scheduled Substances Including Contract Testing Laboratories (ZAF-55) (Effective August 26, 2022)
South African Health Products Regulatory Authority

(Webpage) Clinical Trials Ethics in South Africa (ZAF-51) (Current as of September 26, 2022)
South African Clinical Research Association

(Webpage) National Health Research Ethics Council (ZAF-52) (Current as of September 26, 2022)
Department of Health

Sources Revised During this Update:

(Guidance) Application to Conduct a Clinical Trial - Guidance in Conditions of a Public Health Emergency (G-CTAPHEmerg) (Version 2) (Effective June 1, 2022)
South African Health Products Regulatory Authority

(Guidance) Clinical Guideline (G-Clin) (Version 3) (August 2022)
South African Health Products Regulatory Authority

(Guidance) Guideline for Clinical Trial Participant Time, Inconvenience & Expense (TIE) Compensation Model (G-TIECompensation) (Version 2) (Effective August 1, 2022)
South African Health Products Regulatory Authority

(Guidance) Electronic Submission of Clinical Trial Documents (G-CTA-Electronic) (Version 3) (September 5, 2022)
South African Health Products Regulatory Authority

(Guidance) Emergency Procedures for Clinical Trial Sites (G-EmergencyProc) (Version 3) (August 2022)
South African Health Products Regulatory Authority

(Guidance) Good Pharmacy Practice in South Africa (SA-GPPs) (2018)
South African Pharmacy Council

(Guidance) Liability Insurance for Clinical Trials (G-Insurance) (Version 3) (August 2022)
South African Health Products Regulatory Authority

(Guidance) Oversight and Monitoring in Clinical Trials (G-Monitor) (Version 4) (August 2022)
South African Health Products Regulatory Authority

(Guidance) Guideline for Post Clinical Trial Access (PTA)/Continued Access (G-PostCTAccess) (Version 4) (August 2022)
South African Health Products Regulatory Authority

(Guidance) Guideline for the Procedure of Consultation Meetings with Clinical Trial Applicants (G-ConsultMtg) (Version 2) (August 3, 2022)
South African Health Products Regulatory Authority

(Form) Application for Additional Investigator(s) or Change of Investigator(s) and Application for Additional Sites (ZAF-21) (Version 4) (GLF-CEM-CT-01D) (September 2022)
South African Health Products Regulatory Authority

(Form) Application for Protocol Amendment to Approved Trial (ZAF-20) (Version 4) (GLF-CEM-CT-01C) (September 2022)
South African Health Products Regulatory Authority

(Form) Application to Conduct a Clinical Trial (ZAF-23) (Version 7) (GLF-CEM-CT-01A) (June 2022)
South African Health Products Regulatory Authority

(Form) Biomedical Research Ethics Committee Application Form (ZAF-24) (Version 2) (2017)
Biomedical Research Ethics Committee, University of Kwazulu-Natal

(Form) Notification Studies: Phase IV (ZAF-17) (Version 4) (Effective September 5, 2022)
South African Health Products Regulatory Authority

(Form) Research Ethics Committee Application Form (ZAF-22) (Version 3) (January 2022)
Human Sciences Research Council (HSRC), South Africa

(Form) Six Monthly Progress Report Form for Clinical Trials (ZAF-18) (Version 4) (June 2022)
South African Health Products Regulatory Authority

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