医学信息2016,Vol.29Issue(15):374-374,375,2.
浅谈药品行政受理审评审批制度的重大变革
Discussion on the Major Changes of Drug Administration Acceptance Review and Approval System
王姝 1单晓晖 2王博 3邢程 1孟雪莲4
作者信息
- 1. 辽宁省食品药品监督管理局行政服务中心,辽宁 沈阳 110003
- 2. 辽宁省药械审评与监测中心,辽宁 沈阳 110003
- 3. 辽宁省医疗器械检验检测院,辽宁 沈阳 110000
- 4. 辽宁大学,辽宁 沈阳 110000
- 折叠
摘要
Abstract
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.关键词
药品/行政受理/审评审批/变革Key words
Drug/Administrative processing/Examination and approval/Change引用本文复制引用
王姝,单晓晖,王博,邢程,孟雪莲..浅谈药品行政受理审评审批制度的重大变革[J].医学信息,2016,29(15):374-374,375,2.