Clinical trials in South Africa — worldwide accepted data

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.

Clinical Trial in SA