近年来药品安全已成为国内外关注的焦点议题,这和人民福祉、公众健康都息息相关。但在如此一个具有高度技术性、专业性的领域中,值此《药品管理法》修改初起、药品安全监管制度处于抚今追昔之机,革故鼎新之期时,如何以行政法学理论为主轴,去直面药品监管中的问题,给出法律学层面的学理议论,给出切中要害的因应之道,就成为迫切的课题和难题。本组论文反映了新生代行政法学者关注行政法新发展,关注具体行政领域,关注法律制度改革的努力。宋华琳借助行政组织法、行政程序法、全球行政法理论,并间或以美国法为借镜,分析中国药 In recent years, drug safety has become the focus of attention at home and abroad, which is closely related to people’s wellbeing and public health. However, in such a highly technical and professional field, from the very beginning of the revision of the Drug Administration Law, the drug safety regulatory system is in the midst of reforming the past and taking the administrative law theory as its main axis to face up to drugs The problems in regulation and the theory and theory of jurisprudence are given. It is an urgent task and a difficult problem to give a clear response to the problem. This group of papers reflects that the new generation of administrative law scholars pay attention to the new development of administrative law, pay attention to specific administrative areas, and pay attention to the reform of the legal system. With the help of administrative organization law, administrative procedural law and global administrative law theory, Song Hualin analyzes Chinese medicine