##  [South Africa: Clinical Trial Liability Insurance Guideline](/mandate/south-africa-clinical-trial-liability-insurance-guideline) 

March 27, 2026

The South African Health Products Regulatory Authority (SAHPRA) released a guideline outlining insurance requirements for interventional clinical trials involving human participants, aimed at ensuring participant protection and Regulatory clarity during clinical trial approvals.

#### Key Highlights:

- **Policy Focus:**
    - Establishes clear insurance requirements for clinical trials involving human participants to ensure adequate risk coverage.
- **Scope:**
    - Applicable to all interventional clinical trials submitted to SAHPRA for approval.
- **Key Requirements / Provisions:**
    - Mandatory Insurance Coverage: Insurance is required for all interventional clinical trials involving human participants.
    - Participant Protection: Sponsors/applicants are expected to provide compensation for trial-related injuries, including death, even in the absence of legal liability.
    - Informed Consent Transparency: Informed consent documents must clearly outline procedures for reporting trial-related harm and details on compensation and treatment.
    - Insurance Certificate Submission: A valid insurance certificate with specified details must be submitted as part of the clinical trial application.
    - Claims Process Clarity: Defined procedures for handling and processing compensation claims related to trial injuries.
- **Regulatory Updates:**
    - Administrative update clarifying insurance requirements for clinical trial approvals (effective March 27, 2026).
- **Regulatory Goals:**
    - Strengthen participant safety and ethical standards in clinical trials.
    - Ensure consistent and transparent insurance practices across sponsors and applicants.



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Source

[https://www.sahpra.org.za/document/guideline-for-liability-insurance-for-clinic…](https://www.sahpra.org.za/document/guideline-for-liability-insurance-for-clinical-trials/)

 

 

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