South Africa Profile Updated

The South Africa profile in ClinRegs has been reviewed and updated with the following information:

Updated ethics in health research guidelines from the National Department of Health (See the Ethics Committee, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Specimens topics)
2024 communication from the South African Health Products Regulatory Authority (SAHPRA) on training requirements for good clinical practice (See Site/Investigator Selection section)
SAHPRA clinical trials committee meeting and submission dates for 2025 (See Scope of Assessment, Submission Process, and Timeline of Review sections)
SAHPRA communication regarding import licenses for clinical trials (See Manufacturing & Import section)
Additional information on ethics committee registration with the National Health Research Ethics Council (See Oversight of Ethics Committee section)
Updated SAHPRA payment guidance (See Requirements)
Updated application form to the Human Research Ethics Committee, University of the Witwatersrand, Johannesburg (See Forms)
World Health Organization’s Good Clinical Laboratory Practice (See Additional Resources)

Sources Added During this Update:

(Communication) South African Good Clinical Practice (GCP) Training Post Covid-19 Pandemic (GCP-Trning) (April 22, 2024)
South African Health Products Regulatory Authority

(Communication) Clinical Trial Applications – Investigational Product Import License (CTA-Import) (September 18, 2024)
South African Health Products Regulatory Authority

(International Guidance) Good Clinical Laboratory Practice (GCLP) (ZAF-2) (2009)
World Health Organization

(Document) Human Research Ethics Committees (RECs) Registered with the National Health Research Ethics Council (NHREC) (ZAF-13) (Date Unavailable)
National Health Research Ethics Council

(Webpage) Registration (ZAF-12) (Current as of January 17, 2025)
National Health Research Ethics Council

Sources Revised During this Update:

(Guidance) South African Ethics in Health Research Guidelines: Principles, Processes and Structures (G-EthicsHR-ZAF) (3rd Edition) (2024)
National Department of Health

(Guidance) SAHPRA Payment Guideline (G-SAHPRAFees) (Version 8) (November 30, 2023)
South African Health Products Regulatory Authority

(Document) Clinical Trials Committee Meeting and Submission Dates for 2025 (ZAF-11) (Version 1) (October 7, 2024)
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 4.00) (November 6, 2024)
National Health Research Ethics Council

(Form) Application to the Human Research Ethics Committee: (Medical) (ZAF-45) (Version 4) (2025)
Human Research Ethics Committee, University of the Witwatersrand, Johannesburg

(Form) Research Ethics Committee Application Form (ZAF-22) (Version 5) (December 6, 2024)
Human Sciences Research Council (HSRC), South Africa

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