我国药品技术指导原则体系建设回顾与展望

doi:10.19803/j.1672-8629.20220351

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (10): 1045-1049.
DOI: 10.19803/j.1672-8629.20220351

• 药品监管动态研究专栏 • 上一篇下一篇

我国药品技术指导原则体系建设回顾与展望

沙明泉, 张亚伟, 周红洁, 温宝书^*

国家药品监督管理局药品审评中心, 北京100022

收稿日期:2022-06-27 出版日期:2022-10-15 发布日期:2022-10-17
通讯作者: ^*温宝书,男,硕士,高级工程师,药品审评管理。E-mail：wenbsh@cde.org.cn
作者简介:沙明泉,女,硕士,主管药师,药品审评管理。
基金资助:
重大新药创制国家科技重大专项2017年度（2017ZX09101001-001-002）

A comparative progress and prospect for drug technological guidances system in China

SHA Mingquan, ZHANG Yawei, ZHOU Hongjie, WEN Baoshu^*

Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China

Received:2022-06-27 Online:2022-10-15 Published:2022-10-17

摘要/Abstract

摘要： 目的为完善我国药品技术指导原则体系建设,促进药品质量保障机制提供建议。方法通过查阅法规和文献,对比分析国家药品监督管理局、美国食品药品监督管理局及欧洲药品管理局已发布的指导原则,并结合近年来我国药品技术指导原则的发展现状和实践经验进行回顾分析。结果和结论 提出了加强中国药品技术指导体系建设的对策和建议。

关键词: 药品技术指导原则体系, 药品技术指导原则, 药品注册, 药品技术审评质量

Abstract: Objective To provide some benefit references for being perfected to the Drug Technological Guidances System and promotes drug quality assurance mechanism. Methods By consulting regulations and literatures, the published drug technological guidances by National Medical Products Administration(NMPA), Food and Drug Administration (FDA) and European Medicines Agency (EMA) were compared, and the development status and practical experience of China's drug technical guidelines in recent years were reviewed. Results and Conclusion The countermeasures and suggestions for strengthening drug technological guidances system in china are put forward.

Key words: drug technological guidances system, drug technological guidances, drug registration, drug quality management in review

中图分类号:

R954

沙明泉, 张亚伟, 周红洁, 温宝书. 我国药品技术指导原则体系建设回顾与展望[J]. 中国药物警戒, 2022, 19(10): 1045-1049.

SHA Mingquan, ZHANG Yawei, ZHOU Hongjie, WEN Baoshu. A comparative progress and prospect for drug technological guidances system in China[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1045-1049.

参考文献

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我国药品技术指导原则体系建设回顾与展望

A comparative progress and prospect for drug technological guidances system in China

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