中国药品审评法律制度的行政法改革  

Administrative Law Reform of Drug Review Regime in China

作　　者：宋华琳[1] 

机构地区：[1]南开大学法学院

出　　处：《行政法学研究》2014年第3期3-12,共10页ADMINISTRATIVE LAW REVIEW

基　　金：国家社会科学基金"药品安全监管的行政法研究"(编号:09CFX020)的中期成果

摘　　要：药品审评作为行政许可的表现形式,是一种重要的事先规制手段。通过建构行政治理网络,厘清政府部门与技术审评机构的关系,强化国家食品药品监督管理总局药品审评中心的能力建设,合理配置中央和地方权力,完善专家咨询制度,可以改进药品审评能力。通过制定药品审评程序规范,建构优先审评程序,完善沟通交流机制,恪守药品审评时限,可以简化和优化行政程序。未来应注意药品审评技术指导原则国际化与本土化的结合,制定适合中国实际需要的药品技术审评指导原则。《化学药品CTD格式申报资料撰写要求》的颁布,凸显了全球行政法及药品审评国际化的趋势。Being as the illustration of administrative license, the drug review is an important prior regulation method. For enhancing the drug review ability, much should be done in many fields including the construction of administrative governance network, the clariifcation of relationship between government organs and technical review institutions, the capacity building strengthen of the drug evaluation center of CFDA, appropriate allocation between central and local powers, and the improvement of expert consultation procedure. Moreover, through the formulation of drug review procedure standard, the construction of priority review procedure, and perfection of communication mechanism, as well as the abidance of drug review time limitation, the administrative procedure can be simpliifed and optimized. In future, the combination of global and local technical guidelines for drug review should be paid more attention in order to make up one suitable for China’s practical requirement. The release of the Declared Data Writing Requirement of Chemicals in CTD Format highlights the trends of global administrative law and drug review internationalization.

关 键 词：药品审评 行政法 行政程序 全球行政法 治理网络 

分 类 号：D922.16[政治法律—宪法学与行政法学]