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药品管理法律责任的制度创新
引用本文:刘炫,宋华琳.药品管理法律责任的制度创新[J].中国药事,2019,33(11):1212-1216.
作者姓名:刘炫  宋华琳
作者单位:南开大学法学院, 天津 300350,南开大学法学院, 天津 300350
基金项目:国家社会科学基金2017年年度项目“合作规制的行政法研究”(编号17BFX004)
摘    要:目的:评析2019年版《药品管理法》中的法律责任制度的创新,明确药品市场主体的主体责任和药品监管者的监管责任,以期减少药品违法事件的发生,保证公众用药安全。方法:对比2001年版《药品管理法》,结合行政法原理,加之比较法的视角,对2019年版《药品管理法》进行解析。结果与结论:2019年版《药品管理法》强化了法律责任的重要性,设定了更为严格的法律责任,通过体系化的制度设计和完善的法律责任机制,提高了违法者的违法成本,有助于遏制和惩戒违法行为。

关 键 词:药品管理法  法律责任  行政处罚
收稿时间:2019/10/19 0:00:00

The Institutional Innovation of Legal Liability in the Drug Administration Law
Liu Xuan and Song Hualin.The Institutional Innovation of Legal Liability in the Drug Administration Law[J].Chinese Pharmaceutical Affairs,2019,33(11):1212-1216.
Authors:Liu Xuan and Song Hualin
Institution:School of Law, Nankai University, Tianjin 300350, China and School of Law, Nankai University, Tianjin 300350, China
Abstract:Objective:To analyze the innovation of the legal liability system in the Drug Administration Law (2019 edition), clarify the main liability of drug market subjects and the regulatory liability of drug regulators, in order to reduce the occurrence of drug violations and ensure the safety of public drug use. Methods:The Drug Administration Law (2019 edition) was analyzed by comparing with the Drug Administration Law (2011 edition) based on the principles of administration law and the comparison method. Results and Conclusion:The Drug Administration Law (2019 edition) strengthens the importance of legal liability, sets up more rigorous legal liability, and raises the cost of lawbreaking through systematic institutional design and perfect legal liability mechanism, which helps to curb and punish illegal behaviors.
Keywords:the Drug Administration Law  legal liability  administrative penalty
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