Comments to be sent to email@example.com
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.
The guideline represents the South African Health Product Regulatory Authority’s (SAHPRA) current thinking on the quality, safety, and efficacy of these medicines. Annexures associated with this guideline have been published for public comment prior to implementation. In the interest of focus, only the proposed additional Annexures are included to amend version 4 of the guideline published in June 2020 (7.04_SE_Health_Supplements_Jun20_v4 )
In assessing the safety, efficacy and quality of health supplement and preparations the attached Annexures M and N have been developed to guide the use of the substances listed therein when used in Complementary Medicines as Health Supplements. The following two Annexures M and N to the Guideline 7.04 are now published for comment.
The purpose of Guideline 7.06 (Complementary Medicines – Guidance on specified substances) is to provide guidance to applicants on the use of specified substances in Complementary Medicines and their further application for registration.
Following the amendments to the Schedules as published on the 22 May 2020, SAHPRA intended to develop and publish guidance on the use of Cannabidiol as a specified substance used in Complementary Medicines and list Cannabidiol in annexures to Guideline 7.06 bearing in mind any limitations imposed by the Schedule inscription for CBD.
In assessing the safety, efficacy and quality of Cannabidiol (CBD) the attached Annexure has been developed to guide the use of the substances listed therein when used in Complementary Medicines as Health Supplements. The attached Annexure 4: Cannabidiol (CBD) to the Guideline 7.06 is now published for comment.