Communication to industry – 7.04 Health Supplements Safety and Efficacy

The purpose of Guideline 7.04 (Complementary Medicines - Health Supplements Safety and Efficacy) is to provide clear guidance with regard to the safety and efficacy (SE) requirements for registration of Health Supplements as a subset of complementary medicines in South Africa in the Common Technical Document (CTD) format. The intent of this document is to ensure that the levels of evidence for SE are rigorous enough to protect public health and maintain consumer confidence, while providing a clearly defined pathway to register health supplements.

2022 Mar