Interrogating the Framework for the Regulation of Complementary Medicines in South Africa

Background Research and development of traditional medicines is one of the areas identified in South Africa's National Drug Policy (NDP). Worldwide, the safety, quality, efficacy, availability, and regulation of traditional, complementary, and alternative medicines (T/CAMS) are debated by policy makers, healthcare professionals, and the public. In 2013, regulations for the registration of Complementary Medicines (CM) sold in South Africa were gazetted by the South African Minister of Health. 194Guidelines and associated documentation for prospective and retrospective product registration have now been finalised to facilitate the process. However, there appears to be continued work needed with respect to achieving exact and appropriate definitions of what constitute complementary medicines, including the place of African Traditional Medicines (ATM), the disciplines currently included (and excluded), and the implementation plan by the Medicines Control Council (MCC) (now known as the South African Health Products Regulatory Authority [SAHPRA]). The framework has been hailed by many as a progressive step which will bring rationality to an industry that has been perceived as dangerously unregulated, to the detriment of public health. Relevance This chapter provides insight into the evolution of the complementary medicine regulatory framework in South Africa and highlights important issues around Quality, Safety, and Efficacy (QSE) requirements of the registration regime currently unfolding. Overall, this chapter creates awareness among the public, researchers, policy makers, and industry about the scientific approach to medicine regulation and the potential opportunities and challenges that lie ahead. It also identifies gaps which need to be addressed. In South Africa, various forms of medicine appear to exist in the healthcare space, namely, conventional medicine, indigenous African traditional medicine (ATM), and complementary and alternative medicine (CAM). This chapter provides an overview of CAM and describe what steps South Africa has taken to regulate the medicines and what challenges lie ahead. It proposes that the capacity being built by the regulatory authority in the sector can be used to extend regulation to pharmaceutically packaged ATM but that lessons should also be drawn from other African countries. In South Africa, the Medicines Control Council (MCC) is the statutory council set up by the Medicines and Related Substances Act , which through t