Research on the registration path and strategy of Traditional Chinese Medicine products in South Africa / 国际中医中药杂志

ABSTRACT

This paper analyzes the registration regulations and guidelines of Traditional Chinese Medicine (TCM) products in South Africa, summarizes the registration path of TCM products in South Africa, analyzes the Common Technical Document (CTD) data required for registration from the aspects of quality control, safety and effectiveness, and discusses the registration strategy of TCM products in South Africa. This paper suggests that the strategies could include effective management and control of the registration risk of TCM and steady promotion of the products; TCM enterprises can first register low-risk TCM products, then open the South African TCM market, and promote the registration of high-risk TCM products after accumulating some experience; TCM enterprises need to have the awareness of promoting the inheritance, innovation and development of TCM, increase the investment in clinical trials of TCM products, and supplement the clinical effectiveness and safety data of TCM products; Strengthen the quality control of TCM and build an international brand of TCM.