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Clinical trials in South Africa – worldwide accepted data – Elexes
Elexes Medical Consulting

Clinical trials being a resource, cost, and time extensive process, identifying the right location for a clinical trial is paramount. Republic of South Africa (RSA) is one such location that can be apt because:

  • RSA, a Tier 1 country for the USFDA, is exempted from export notification for Investigational Devices per 21 CFR 801(e)(2) and the IDE regulations as long as the SAHPRA requirements are met
  • RSA clinical trial results can be used to support marketing authorization in developed countries, as RSA regulatory framework and standard of care are highly credible
  • The country offers a diversified patient population which is representative of many developed countries  

Some requirements: 

  • Registration of the Clinical Trial must be done using RSA Human Research Electronics Application System of the National Health Research Ethics Committee (NHREC)
  • The Local Ethics committee of RSA, accredited by the NHREC, must approve the clinical trial
  • The Ethics approval and SAHPRA Clinical Trial Application (CTA) approval can be pursued in parallel  

The review timelines, applicable fees, and expected decisions associated with a CTA are below.


Picture Credits: Freepik

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