医疗机构药事管理现行主要法律法规剖析

Leading Laws and Regulations on Pharmaceutical Administration in Medical Institutions

目的对我国医疗机构药事管理相关现行法律法规进行剖析,为完善药品管理各环节法律法规提供参考。方法参考相关法规,对国家已颁布的药事管理相关现行法律法规进行汇总、分类,对发布时间、发布单位和发布内容进行分析。结果与结论我国现行药事管理各环节立法规范工作虽然取得了一定成果,但立法层次、法规体系、责任体系等方面有待提高和完善。应加强药事管理重点领域和关键环节立法,及时修订现有法律法规,逐步形成满足管理要求的较为成熟的药事管理法律法规体系。

Objective To analyze laws and regulations on pharmaceutical administration in medical institutions in China and provide reference for related revisions.Methods The laws and regulations on pharmaceutical administration issued in China were collected and categorized.The time these laws and regulations were issued,the issuers,and the content were analyzed.Results and Conclusion Despite many legislative achievements on pharmaceutical administration,there are still some problems that need to be addressed,involving the hierarchies of legislation,legal systems and accountability systems.Efforts should be made to strengthen legislation of pharmaceutical administration in key areas and revise laws and regulations in force without delay so as to build up a full-fledged regulatory system for pharmaceutical affairs to serve the purpose of management.