Strategy and thinking of the development and review policies of traditional Chinese medicine (TCM) new drugs taking "three Chinese patent medicines and three TCM prescriptions" as examples

ABSTRACT

A large number of traditional Chinese medicine (TCM) prescriptions have played an active role in the prevention and treatment of emerging epidemic diseases, which contain huge potential of research and development (R&D). However, in recent years, few TCM new drugs have been approved for market and the industry is in a downturn. With examples of the recent drug review policies and the "three Chinese patent medicines and three TCM prescriptions" for Corona Virus Disease 2019 (COVID-19), this article proposed a series of strategies from the perspectives of review and R&D of TCM new drugs as well as resource allocation. The strategies are improving the R&D layout of TCM new drugs, clarifying the evaluation criteria of human experience evidence, supervising the syndrome indications for TCM new drugs other than diseases, implementing differentiation competitive strategy, applying multi-disciplinary methods in prescription screening, applying integrated research design, increasing investment in high-quality clinical research, and integrating resources to break through international barriers. © 2020, Chinese Journal of New Drugs Co. Ltd. All right reserved.