论药品监管指导原则的法律渊源与法律运用  

Review on the Legal Source and Application of the NMPA’s Guidelines on Drug Regulation

作　　者：王波 邵蓉[1] WANG Bo;SHAO Rong(Institute of Regulatory Science for Medical Products,China Pharmaceutical University)

机构地区：[1]中国药科大学药品监管科学研究院

出　　处：《中国食品药品监管》2022年第11期54-61,共8页China Food & Drug Administration Magazine

摘　　要：目的:进一步厘清药品监管指导原则与我国行政法律体系的关系,推动指导原则制度的科学化、法治化。方法:运用法解释学与比较法学的方法,讨论指导原则的法律渊源与法律运用。结果:《药品管理法》《药品管理法实施条例》等构成了药品监管指导原则的基本法律渊源,在相关条文中尚未正面定义指导原则的概念、功能与边界,对指导原则的非强制属性可适当加强。《行政许可法》等行政法律同样构成了指导原则的法律渊源,且指导原则属于行政许可的“标准”,并非与注册审批事项无关。结论:药品监管指导原则制度的完善,需要重视法律渊源问题,并应在法律法规中明确指导原则的具体概念与使用范围。Objective:This paper aims to clarify the relationship between the NMPA’s guidelines and the China's administrative legal system,thus promoting the scientization and legalization of the guidelines.Methods:By the legal hermeneutics and comparative jurisprudence,the legal sources and legal application of the guidelines were discussed.Results:The Drug Administration Law of the People's Republic of China,Regulations for Implementation of the Drug Administration Law of the People's Republic of China,together with other related laws and regulations constitute the basic legal source of the guidelines.However,the guidelines’conception,function and scope of application are not defined clearly in the relevant provisions and the non-mandatory nature of the guidelines could be appropriately strengthened The Administrative License Law of The People's Republic of China and other administrative laws also constitute the legal source of the guidelines,and the guidelines belong to the"standard"of The Administrative License Law,not unrelated to the drug’s registration and approval matters.Conclusions:The improvement of NMPA’s guidelines on drug regulation requires people to pay attention to legal sources.And the guidelines’conception and application scope should be made clear in laws or regulations.

关 键 词：指导原则 法律渊源 行政许可 行政协商 

分 类 号：D90[政治法律—法学理论]