| 我国药品监管实践中存在的法律问题与思考 |
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| 引用本文： | 初炜,贾佩福,刘英伟,吴云红.我国药品监管实践中存在的法律问题与思考[J].中国药事,2010,24(1):11-13,18. |
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| 作者姓名： | 初炜 贾佩福 刘英伟 吴云红 |
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| 作者单位： | 大连医科大学社会科学与管理科学学院,大连,116044 |
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| 摘 要： | 目的探讨我国药品安全监管中存在的法律问题,为《药品管理法》的再修订提供参考。方法采用文献法、专家访谈法,认知药品安全监管方面存在的法律问题。结果《药品管理法》中对于新药定义过于宽泛,以所含成份的有无及含量作为假、劣药细分标准容易造成实际处理上的混乱,对制售假药、劣药的行为处罚过轻,尚未明确药品损害赔偿范围及其责任,药品广告监管体制存在着审批与监管相分离的弊端。结论对《药品管理法》进行再修订十分必要。
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| 关 键 词： | 《药品管理法》 修订 药品安全 监管 |
The Law Problems in the Practice of Drug Supervision in China and Thoughts |
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| Chu Wei,Jia Peifu,Liu Yingwei,Wu Yunhong.The Law Problems in the Practice of Drug Supervision in China and Thoughts[J].Chinese Pharmaceutical Affairs,2010,24(1):11-13,18. |
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| Authors: | Chu Wei Jia Peifu Liu Yingwei Wu Yunhong |
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| Affiliation: | Chu Wei,Jia Peifu,Liu Yingwei , Wu Yunhong(Social Science , Administration College,Dalian Medical University,Dlian 116044) |
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| Abstract: | Objective Analyze the law problems in the supervision of drug security in China to provide reference for the revise of The Drug Administration Law of China.Methods By the methods of literature research and experts interview to find the law problems in the supervision of drug security.Results The definition of new drug in The Drug Administration Law of China is too broad,it can cause confusion to divide the counterfeit drug and the adulterated drug based on the standards of the ingredients included or not an... |
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| Keywords: | The Drug Administration Law of China revise drug safety supervision |
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