2020年7月1日，我国新版《药品注册管理办法》（《办法》）正式施行，标志着中药注册管理再次迈入崭新时期。新版《办法》突出框架性原则，对新药研发具体技术要求的相关内容不再进行规定，而是以技术指导原则等配套文件的形式另行发布。通过系统回顾《办法》2007年版实施期间的国内中药新药注册审批情况，实证分析我国中药新药研发和注册的现状和可能存在的问题，以期为新版《办法》中药相关配套文件的制定提供参考。

The new version of Measures for the Administration of Drug Registration (Measures) executed on July 1, 2020, which represented that the registration of Chinese medicines in China had entered a new era. The new Measures highlights the framework principles which refers to that specific technical requirements are no longer included into the regulations and will be issued separately as supporting documents. The registration and approval of new Chinese medicines during the implementation of the 2007 version of the Measures are systematically reviewed in this article, and the current status and possible problems of R&D and registration of new TCM drugs in China are analyzed, in order to provide a reference for the related supporting documents of Chinese medicine for the new version of Measures.

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国家社会科学基金青年项目（18CGJ036）