摘要
目的:为修订《药品管理法》提供参考。方法:通过参阅相关文献,对《药品管理法》存在的缺陷和完善的建议进行综合分析。结果与结论:《药品管理法》存在"药品"概念不科学,假劣药划分不合理,未能根据承担过错责任的主次情况、主观因素、造成的后果轻重等因素考虑分级处罚和部分环节立法缺失等一些不完善的地方。可参考美国《食品、药品与化妆品法案》,通过修改"药品"概念和对不合格药品分类、修正原各环节的立法缺失,以及平衡法律义务与法律责任的规定等措施修订《药品管理法》,使其日臻完善。
OBJECTIVE： To provide reference for revising Drug Administration Law. METHODS： By reviewing the pertinent literature, the defects of the Drug Administration Law and the suggestions on its improvement were analyzed comprehensively. RESULTS ＆ CONCLUSIONS： The Drug Administration Law was imperfect in that the concept of ＂drug＂ was not scientific, the division for counterfeit and substandard drugs was not reasonable, graded penalty based on the factors such as the primary- secondary responsibility, subjective factor, the severity of consequence etc was not imposed, and the legislation for some of the links was absent etc. It can take the Food, Drug and Cosmetics Law in US as reference to revise the Drug Administration Law by revising the concept of ＂drug＂, classifying the unqualified drugs, rectifying the legislative absence of the original links, making a balance between legal liability and the legal obligation so as to achieve gradual perfection.
出处
《中国药房》
CAS
CSCD
北大核心
2009年第10期727-732,共6页
China Pharmacy
关键词
药品管理法
缺陷
完善
研究
Drug Administration Law
Defect
Improvement
Research
