日本汉方制剂分类管理对中国中成药管理的启示  

Enlightenment of the Classification Management of Japanese Kampo Preparations to the Management of Chinese Patent Medicines

作　　者：赵静[1] 蒋蓉[1] 邵蓉[1] ZHAO Jing;JIANG Rong;SHAO Rong(China Pharmaceutical University,Key Laboratory of Drug Regulatory Innovation and Evaluation,Nanjing 211198,China)

机构地区：[1]中国药科大学药品监管创新与评价重点实验室,南京211198

出　　处：《中国现代应用药学》2022年第12期1640-1645,共6页Chinese Journal of Modern Applied Pharmacy

基　　金：国家社会科学基金重大项目(15ZDB167)。

摘　　要：目的分析日本感冒药汉方制剂的管理体系,并对典型制剂葛根汤汉方制剂的审批情况、报销管理进行剖析,提出促进中国中成药发展的相关完善建议。方法采用文献分析法,查阅日本汉方制剂的文献、官方政策与标准等,梳理日本汉方制剂分类管理制度,分析日本已上市葛根汤汉方制剂情况。结果日本汉方制剂分类管理体系较为成熟,对非处方类汉方制剂有专门的简化审批流程。结论建议中国明确中成药科学分类管理制度,改进中成药说明书内容,简化临床经验丰富且风险较低的中成药审评审批。OBJECTIVE To analyze the management system of Japanese cold medicine Kampo preparations,to analyze the approval and reimbursement management of typical preparations of Gegen decoction Kampo preparations,and to put forward relevant suggestions to promote the development of Chinese patent medicines in China.METHODS The literature analysis method was used to check the literature,official policies and standards of Kampo preparations in Japan,sort out the classification management system of Kampo preparations in Japan,and analyze the situation of medicines.RESULTS The classification and management system of Kampo preparations in Japan was relatively mature,and there was a special simplified approval process for non-prescription Kampo preparations.CONCLUSION It is recommended that China may clarify the scientific classification management system of proprietary Chinese patent medicines,improve the contents of the instructions of proprietary Chinese patent medicines,and simplify the review and approval of proprietary Chinese patent medicines with rich clinical experience and low risk.

关 键 词：汉方制剂 分类管理 中成药 简化审批 案例分析 葛根汤 

分 类 号：R954[医药卫生—药学]