結合當前中藥注冊分類的修訂形勢，對中藥新藥申報資料與天然藥物新藥技術要求進行了思考。不同于化學藥新藥，中藥新藥復方制劑大多具有可供評價的人用經驗，考慮如何應用人用經驗的不同證據分級，對申報資料進行減免。醫(yī)療機構中藥制劑具有較高證據級別的中藥臨床應用經驗，建議對醫(yī)療機構中藥制劑的生產與使用情況進行調研，促進醫(yī)療機構中藥制劑向中藥新藥轉化，為建立符合中藥特色的審評體系提供參考依據。另外，基于天然藥物與中藥的藥用物質均為復雜混合物，建議天然藥物新藥的藥學和藥理毒理學要求與中藥新藥保持一致，天然藥物新藥的臨床要求參考化學藥新藥臨床技術要求。

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.

R951