在法律框架下改进药品标准工作的思考与建议  

Thoughts and Suggestions on Improvement of Drug Standard Administration under the Legal Framework

作　　者：赵宇新[1] 麻广霖[1] 

机构地区：[1]国家药典委员会,北京100061

出　　处：《中国药品标准》2016年第2期83-87,共5页Drug Standards of China

摘　　要：目的:聚焦药品标准工作中存在的突出问题,从《药品管理法》法律层面提出改进建议。方法:对药品标准工作中存在的问题进行梳理,分析产生问题的原因,探讨在法律制度设计层面存在的不足,研究提出相关对策。结果:药品标准工作存在不同层级规定的衔接不畅、工作机制不够健全、职责部门权责不清等问题。结论:应以《药品管理法》修订为契机,在法律框架下统筹解决上述问题。Objective：Focus on the questions existed in administration of drug standard, Put forward the improvement proposal from the legal level of the Drug Administration Law.Methods：The questions existed in administration of drug standard were analyzed, de-fects in legal system designing were paid more attentions, and then relevant suggestions were proposed.Results：Some questions exis-ted, such as the harmony of laws and regulations at different levels was unsatisfactory, drug standard′s working mechanism should be reformed, and the responsibilities of relevant departments should be made clear.Conclusion：The questions above should be resolved under the legal framework when revising the Drug Administration Law.

关 键 词：药品标准 机制 药品管理法 修订 

分 类 号：R921.2[医药卫生—药学]