从日本药事法的修订谈我国境外药品委托生产  

Commissioning Manufacture of Overseas Drugs in China in view of the Amendment of the Pharmaceutical Affairs Law in Japan

作　　者：韦晟[1] 顾新[1] 

机构地区：[1]南京大学医学院附属南京鼓楼医院药剂科,南京市210008

出　　处：《中国药房》2008年第10期724-725,共2页China Pharmacy

摘　　要：目的:为我国制药企业发展境外药品委托生产提供参考。方法:对比我国和日本等国药品委托生产注册制度,在分析我国药品委托生产现状的基础上,对我国制药企业承接来自日本等国的境外药品委托生产的可行性进行分析。结果与结论:我国政府和制药企业应抓住日本药事法修订的机遇,创造更有利的条件,力争在境外药品委托生产中有所作为。OBJECTIVE： To provide references for Chinese pharmaceutical enterprises in developing commissioning manufacture of overseas drugs. METHODS： The registration system of medicine commissioning manufacture in China, Japan and other countries were compared. The current status of Chinese drugs commissioning manufacture and the feasibility for Chinese pharmaceutical enterprises to gain commissioning manufacture of overseas drugs were analyzed. RESULTS ＆ CONCLUSIONS： Both the government and pharmaceutical enterprises in China should take advantage of the amendment of the pharmaceutical affairs Law in Japan t＇o contribute to the development of commissioning manufacture of overseas drugs.

关 键 词：药品生产 法规 境外委托 

分 类 号：R951[医药卫生—药学] F273[经济管理—企业管理]