摘要
目的探讨美国放射性药品注册管理的体制机制,为我国放射性药品的管理提供参考。方法分析当前美国放射性药品的定义、法规体系、管理机构、注册管理程序和申请文件要求等。结果与结论美国的放射性药品注册管理制度比较完善,可供借鉴。
Objective To analyze the registration system of radiopharmaceuticals in US and offer some reference for improving the Chinese counterpart system. Methods The definition, law and regulation system, institute of administration, procedure, application documents and other aspects of radiopharmaceuticals were analyzed. Results and Conclusion The registration system of radiopharmaceuticals in US can be used for reference.
出处
《中国药事》
CAS
2012年第6期653-656,共4页
Chinese Pharmaceutical Affairs
关键词
放射性药品
药品注册
药事管理
radiopharmaceutical
drug registration
pharmacy administration
