生物医学转化 (Sep 2022)
Analysis on the effects of the "three combined" evaluation evidence system on the transformation of traditional Chinese medicine new drugs
Abstract
To reflect the characteristics and advantages of Chinese medicine, the national level has proposed to build a evaluation evidence system, that combines Chinese medicine theory, human used experience and clinical trials. This evaluation evidence system not only respects the rules and practice of the research and development (R&D) of TCM new drugs, the inheritance and innovation of TCM theory, the standardized collection and arrangement of human used experience, and the precise design of clinical trials but also helps to generate effective new TCM formulas based on clinical value, optimize the R&D strategies, shorten R&D cycles, reduce R&D risks, and improve the R&D efficiency. The evaluation evidence system has improved the success rate of new drug development in Chinese medicine and solved the problem of insufficient transformation rate of scientific and technological. Based on the "three combined" review evidence system to achieve TCM new drugs transformation, medical institutions can also continuously improve the original innovation ability, clinical R&D level and scientific and technological service ability of TCM new drugs. This model is one of the important paths to promote the transformation of TCM new drugs under policy guidance.
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