Medicines Control Council (MCC): guidelines on complementary medicines

Posted 13 June 2016

A number of updated guidelines for complementary medicines have been published on the MCC web site:

7.01 Complementary Medicines – Discipline Specific Safety and Efficacy V3 13-Jun-2016  –

7.03 Complementary Medicines – Use of the ZA-CTD format in the Preparation of a Registration Application V3 13-Jun-2016  –

7.04 Complementary Medicines – Health supplements Safety and Efficacy V2 13-Jun-2016 –

7.05 Complementary Medicines – Registration Application ZA-CTD – Quality V1 13-Jun-2016 –

The definition of a complementary medicine, to include the category ‘Health Supplements’ as suggested in a previous draft,  is expected to be finalised soon. CAMs will in future be divided into discipline-specific CAMs (linked to the AHPCSA-regulated disciplines) and ‘Health Supplements’. Guidelines on safety and efficacy will be then separated for the two types of CAMs, but the quality guideline and ZA-CTD guidelines are common to both types.

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