日本汉方制剂的品种情况及管理模式分析  

Analysis of the variety status and management mode of japanese kampo medicines

作　　者：孙昱 SUN Yu(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2020年第8期1041-1048,共8页The Chinese Journal of Clinical Pharmacology

摘　　要：日本汉方制剂包含处方药和非处方药两种情况,本文对汉方制剂的生产、销售及获批情况进行了分析。汉方制剂申报非处方药有两个途径,一是适应症分类管理途径,二是品种目录管理途径,本文对这两个申报途径结合汉方制剂说明书进行了举例分析,为我国中药新药及古代经典名方审评审批提供参考。Japanese Kampo products include both prescription and over-the-counter(OTC)medicines.This article analyzes the production,sales,and approval of the Kampo products.There are two ways for Kampo products to submit OTC medicine applications,one is the classification management of indications,and the other is the management of variety catalogs.This article analyzes these two application methods in combination with the Kampo product labelings,and provides references for the review and approval of traditional Chinese medicines and ancient classic prescriptions.

关 键 词：汉方药 医疗用汉方制剂 一般用汉方制剂 适应症分类 品种目录管理 古代经典名方 

分 类 号：R28[医药卫生—中药学]