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国家食品药品监督管理总局自2015年10月以来依据同年国务院出台的有关药品行政受理审评审批的文件要求相继出台了一系列具体举措，大规模推进了受理程序、审评标准和审批制度的改革。本文综合分析了相关法规的意见要点，旨在通过对总局药品行政受理审评审批制度重大改变的总结和论述，协助注册申请人进一步规范药品注册行为。“,”State food and drug supervision and management of administration since October 2015 on the basis of the same drug administration to accept the review introduced the relevant examination and approval by the state council document requirements had issued a series of specific measures and pushed the accepts the application, review standards and the reform of the examination and approval system. This paper comprehensive analyzed the key points of the opinions of the relevant laws and regulations, aimed to review the examination and approval system for the administration of drug administrative processing major changes summarized and discussed, assisting registration applicant further regulated the behavior of drug registration.