结合当前中药注册分类的修订形势，对中药新药申报资料与天然药物新药技术要求进行了思考。不同于化学药新药，中药新药复方制剂大多具有可供评价的人用经验，考虑如何应用人用经验的不同证据分级，对申报资料进行减免。医疗机构中药制剂具有较高证据级别的中药临床应用经验，建议对医疗机构中药制剂的生产与使用情况进行调研，促进医疗机构中药制剂向中药新药转化，为建立符合中药特色的审评体系提供参考依据。另外，基于天然药物与中药的药用物质均为复杂混合物，建议天然药物新药的药学和药理毒理学要求与中药新药保持一致，天然药物新药的临床要求参考化学药新药临床技术要求。

Combined with the revision of the current traditional Chinese medicine (TCM) registration classification, this paper has considered the new TCM application materials and the technical requirements of new natural medicines. Unlike chemical drugs, most of the new TCM compound preparations have experience for people to evaluate, considering how to apply different evidence classifications of human experience, and reduce the application materials. Medical institution TCM preparations have high clinical evidence of clinical application experience. It is recommended to investigate the situation of medical institution TCM preparations, promote the conversion of medical institution TCM preparations into new TCM, and provide reference for the establishment of a review system that conforms to the characteristics of TCM. In addition, based on the complex mixture of natural medicines and TCM, it is recommended that the pharmacy and pharmacological toxicological requirements of new natural medicines should be consistent with the new TCM. The clinical requirements of new natural medicines refer to the clinical technical requirements of new chemical drugs.

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