文章摘要
李桥.论药品监管领域限制从业制度的困境与出路[J].中国药事,2022,36(3):256-262
论药品监管领域限制从业制度的困境与出路
On the Predicament and Outlet of the Legal System of Restricting Employment in the Field of Drug Supervision
  
DOI：10.16153/j.1002-7777.2022.03.003
中文关键词: 药品监管  法律责任  行政处罚  限制从业  制度完善
英文关键词: drug supervision  legal responsibility  administrative penalty  restriction of employment  system consummation
基金项目:
作者单位
李桥 都江堰市市场监督管理局,都江堰 611830 
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中文摘要:
      目的：通过梳理药品领域限制从业法律规范及执法机关在实践中对该法律制度的落实情况，分析规范特点及具体执行中存在的问题，结合实践经验，提出完善建议，为执法人员提供适用该制度的参考依据。方法：对现有药品领域限制从业相关法律法规条款进行归纳，分析其特点及存在问题；对监管部门工作人员及药品生产经营企业进行访谈，了解制度的执行情况及执行困境。结果与结论：药品领域限制从业法律制度作为一种新型的法律责任制度，相关制度建设和实践运用还存在着法律规范不完善、适用标准不明确、运行程序不健全、救济渠道不畅通等诸多法律问题，有必要审视该制度的合理性及法律实效性，并在现有立法格局基础上，完善限制从业规范依据、明确适用标准、健全运行程序、畅通救济渠道，实现该制度的有效执行。
英文摘要:
      Objective：By sorting out the legal norms of restricted employment in the pharmaceutical field and the implementation of the legal system by law enforcement agencies in practice, analyzing the characteristics of the norms and the problems existing in specific implementation, and combining with practical experience, to put forward corresponding suggestions for improvement, so as to provide the reference basis for law enforcement officials to apply the system. Methods: To summarize the existing laws and regulations related to the restriction of pharmaceutical practice, analyze the characteristics and existing problems. Interviews were conducted with the staff of regulatory departments and drug manufacturers to understand the implementation situation and difficulties of the system. Results and Conclusion: As a new kind of legal liability system，The debarment system in the drug field still has many legal problems in the construction and practical application of relevant systems, such as imperfect legal norms, unclear applicable standards, imperfect procedural mechanisms, and unsmooth relief channels. Therefore, it is necessary to examine the rationality of the system and the legal effectiveness. On the basis of existing legislation pattern, the system should be effectively implemented by improving the basis of the restricted practice norms, clarifying the applicable standards, perfecting the operation procedures and unblocking the relief channels.
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