中药新药研发是一项系统工程，涉及多学科的知识和技术方法，并以产业化生产和临床应用为最终目的。自1985年我国施行新的药品注册审评办法以来，我国新药研发及其注册管理经历了30余年的发展过程，也取得了显著的成效。近年来，国家对中药新药研发给予高度重视，预示了新的发展时期的到来。中药新药研发有其自身的特点，应遵循自身的客观规律。基于多年新药研发实践，以中医理论为依据，以“有效性”为核心，以物质为载体，以药代为桥接，提出以“物质-药代-功效”关联的中药创新研发思路，以期为中药新药的高效率、高水平、快转化提供有益的参考。

The research and development (R&D) of new traditional Chinese medicine (TCM) drugs is a systematic project, involving multi-disciplinary knowledge and technical methods, with the ultimate goal of industrialized production and clinical application. Since the implementation of provisions for drug registration in 1985, new drug R&D and registration management have experienced more than 30 years in China and achieved remarkable results. In recent years, the state has attached great importance to the R&D of new TCM drugs, which indicates the arrival of a new development period. The R&D of new TCM drugs has its own characteristics, which should follow the objective law of TCM. According to the R&D practice of new drugs for many years, the authors put forward the innovative R&D ideas of TCM related to “substance-pharmacokinetics-effects”, which is based on TCM theory, with “effectiveness” as the core, substance as the carrier and pharmacokinetics as the bridge, hoping to provide a useful reference for the high efficiency, high level and rapid transformation of new TCM drugs.

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国家自然科学基金重点项目（81830111）；国家自然科学基金区域联合基金项目（U21A20406）；国家重大新药创制计划课题（2018ZX09721004-006）；“中医药现代化研究”重点专项（2019YFC1711201）