人用经验在中药新药申报中的应用研究与中药新药申报的拓展思考  

Human experience in new drug application of traditional Chinese medicine and expansion of new drug application of traditional Chinese medicine

作　　者：孙昱 孙国祥[2] 李焕德[3] SUN Yu;SUN Guo-xiang;LI Huan-de(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022;College of Pharmacy,Shenyang Pharmaceutical University,Shenyang 110016;The Second Xiangya Hospital of Central South University,Changsha 410011)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022 [2]沈阳药科大学药学院,沈阳110016 [3]中南大学湘雅二医院药学部,长沙410011

出　　处：《中南药学》2020年第12期1941-1944,共4页Central South Pharmacy

基　　金：国家自然科学基金项目(No.81573586)。

摘　　要：本文探讨了中药新药的人用经验应用思路和中药新药申报与创新问题。结合澳大利亚古方来源中成药品种情况、澳大利亚登记类药品管理、日本汉方制剂品种情况、日本非处方药管理模式进行汇总分析。应用人用经验的重点在于不同风险程度和不同表述方式所对应的适应证需提供不同等级的临床研究证据。不同风险中药新药适应证可选择不同的表述方式,不同的表述方式可考虑按对应体系的临床评价标准来进行评估。需重视做好中药新药传承与创新的政策平衡,建议在给予具有人用经验的中药注册申请政策优惠的同时,考虑给经实验优化的中药获批上市后销售上的利好。This paper discusses the application of human experience in the innovation of new Chinese medicines.We summarized the research experience of Australian Chinese patent medicine from ancient prescriptions,Australian listed medicine management,variety of Japanese Kampo products,and over-the-counter management models in Japan.Application of human experience means that different levels of risk and different indications demands different levels of clinical research evidence.Indications for new medicines with different risks may have different expressions,and different expressions shold be reviewed according to the clinical evaluation standards of the corresponding system.It is necessary to pay attention to the policy balance between inheritance and innovation of new Chinese medicine.Traditional Chinese medicine with human experience and experimentally optimized traditional Chinese medicines should both considered in market approval approved for marketing.

关 键 词：人用经验 中药新药申报 澳大利亚登记类药品 日本汉方制剂 非处方药 适应证分类管理 

分 类 号：R95[医药卫生—药学]