日本汉方制剂对我国经典名方注册监管的启示
The Inspiration of Registration and Administration to the Classical Representative Famous Prescription in China by Kampo Extract Product in Japan
薛斐然 1周贝1
作者信息
- 1. 国家食品药品监督管理总局药品审评中心 北京100038
- 折叠
摘要
日本汉方制剂在日本的注册监管与中国来源于古代经典名方的中药复方制剂(以下简称“经典名方”)存在一定的相似之处.本文从日本汉方制剂的特点、注册监管的背景和特点进行了分析说明,建议中国有关部门在制定来源于古代经典名方的中药复方制剂的具体目录时,充分考虑日本汉方制剂发展过程中所走的弯路和目前日本药政部门所开展的再评价和规范化相关工作.
Abstract
There are part of similarities between kampo extract product in Japan and classical representative famous prescription in China.This paper analyzes and explains the characteristics of kampo extract product in Japan and the registration management background,suggests the relevant departments to fully consider the mistakes in the process of kampo extract product development and the re-evaluation and standardization work Japanese drug regulatory authorities have done when formulate the detailed catalogue of classical representative famous prescriptions in China.
关键词
日本汉方制剂/经典名方/注册监管Key words
Kampo extract product in Japan/classical representative famous prescription/registration management引用本文复制引用
基金项目
国家中医药管理局2012年度中医药行业科研专项(201207009)
出版年
2017
国家科技期刊平台
NSTL
维普
万方数据