The reform of the review and approval system for Traditional Chinese Medicine (TCM) continues to advance with the introduction of a new registration classification and the establishment of a review and approval evidence system. This new registration process established a novel review and approval evidence system, which combines the TCM theory, human use experience and clinical trials. Ramulus Mori (Sangzhi) alkaloids Tablets are a brand new drug. It is the first botanical natural hypoglycemic drug, and a new model of TCM review and approval evidence system has gradually been developed through contemporary research. In this paper, we discuss the registration process of new Chinese medicine drugs under the "three integrated review and approval system", retrace the development process of Mulberry alkaloid tablets, and discuss the opportunities and challenges encountered under the "three integrated" evidence system to provide feasible strategies and reference models for the development of Chinese medicine and the development of botanical drugs in the world.
Keywords: Alpha-glucosidase inhibitors; Chinese medicine review and approval challenges; National Medical Products Administration; Ramulus Mori alkaloids; Type 2 diabetes.
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