South Africa Profile Updated

March 19, 2026
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The South Africa profile in ClinRegs has been reviewed and updated with the following information:

  • South African Health Products Regulatory Authority (SAHPRA)’s application requirements from 2025 on proof of insurance (See Insurance & Compensation)
  • SAHPRA safety reporting guidance on the use of the International Council for Harmonization (ICH)’s E2B electronic format and reference to ICH technical specifications for E2B formats (See Safety Reporting)
  • SAHPRA press release from 2025 on becoming a member of ICH (See Regulatory Authority)
  • Details on National Health Research Ethics Council (NHREC) registration requirements for ethics committees (See Oversight of Ethics Committees)
  • Updated information on NHREC functions (See Oversight of Ethics Committees)
  • Updated guidelines on ethical considerations in seeking informed consent from the Health Professions Council of South Africa (See Participant Rights)
  • Reference to SAHPRA core business escalation procedures when contacting the relevant Clinical Trials Unit (See Regulatory Authority)
  • Updated SAHPRA good manufacturing practice guideline (See Requirements)
  • Amendments to the Children’s Act (See Requirements)

Sources Added During this Update:

(Communication) Clinical Trial Insurance for New Clinical Trial Applications (CTInsurance) (December 19, 2025)
South African Health Products Regulatory Authority 

(Communication) Core Business Escalation Procedure (EsclatProc) (November 7, 2025)
South African Health Products Regulatory Authority

(Communication) Electronic Submission of Serious Adverse Events (SAE) Reports – E2B Reporting (SAE-E2B) (December 17, 2025)
South African Health Products Regulatory Authority

(Notice) Registration of a Research Ethics Committee (REC) with the National Health Research Ethics Council (NHREC) (ECRegstrn) (November 14, 2025)
National Health Research Ethics Council

(International Guidance) Electronic Standards for the Transfer of Regulatory Information (ESTRI) (ZAF-31) (Current as of March 19, 2026)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use

(Press Release) SAHPRA Accepted as a Member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) (ZAF-29) (December 1, 2025)
South African Health Products Regulatory Authority

Sources Revised During this Update:

(Legislation) Children’s Act 38 of 2005 (ChildrensAct) (Last Amended May 28, 2025)
Parliament

(Guidance) Ethical Guidelines for Good Practice in the Health Care Professions: Booklet 4: Seeking Patients’ Informed Consent: The Ethical Considerations (G-GPHlthCare-IC) (Last Updated December 2021) 
Health Professions Council of South Africa

(Guidance) Guidelines to Good Manufacturing Practice for Medicines (SA-GMP) (Version 9) (Effective November 2025)
South African Health Products Regulatory Authority

(Webpage) National Health Research Ethics Council (ZAF-52) (Current as March 19, 2026)
Department of Health

(Webpage) Registration of Research Ethics Committees (ZAF-12) (Current as of March 19, 2026)
National Health Research Ethics Council

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