CAJ | 학술논문

药品安全问题是影响我国国计民生和社会秩序的重要问题，我国药品监管制度本身的不完善，行刑衔接过程中存在的诸如相关立法不足、信息交流闭塞、执法人员缺乏移送意识以及欠缺有效监督等一系列问题是隐藏在层出不穷的假药劣药事件的背后原因。美国整个监管体制及衔接模式促成了美国药品安全的良好秩序，对我国有很大的借鉴意义，与之相较，我国从整个法规体系、机构设置、人员素质到监督管理等方面都亟需改革与完善。
약품안전문제시영향아국국계민생화사회질서적중요문제，아국약품감관제도본신적불완선，행형함접과정중존재적제여상관입법불족、신식교류폐새、집법인원결핍이송의식이급흠결유효감독등일계렬문제시은장재층출불궁적가약렬약사건적배후원인。미국정개감관체제급함접모식촉성료미국약품안전적량호질서，대아국유흔대적차감의의，여지상교，아국종정개법규체계、궤구설치、인원소질도감독관리등방면도극수개혁여완선。
Drug safety is an important issue affecting China's national economy and social order. Such factors contribute to an endless stream of counterfeit or substandard drug events as imperfect drug regulatory system, the problems in the process of convergence like the lack of relevant legislation, occlusion of the exchange of information, law enforcement officers lack transferred to consciousness and lack of effective supervision. The whole regulatory system and the convergence mode of the United States have contributed to the good order of the American drug safety, which has a great significance to our country.