美国FDA监管科学研究进展及启示

doi:10.19803/j.1672-8629.20220453

中国药物警戒 ›› 2022, Vol. 19 ›› Issue (10): 1055-1059.
DOI: 10.19803/j.1672-8629.20220453

• 药品监管动态研究专栏 • 上一篇下一篇

美国FDA监管科学研究进展及启示

沙明泉, 李楠楠^△, 夏文静, 魏群, 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:2022-08-02 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。^△为并列第一作者。
基金资助:
重大新药创制国家科技重大专项2017年度（2017ZX09101001-001-002）

Research and reflection on regulatory science developments of U.S. FDA

SHA Mingquan, LI Nannan^△, XIA Wenjing, WEI Qun, WEN Baoshu^*

Center for Drug Evaluation, NMPA, Beijing 100022, China

Received:2022-08-02 Online:2022-10-15 Published:2022-10-17

摘要/Abstract

摘要： 目的介绍美国食品药品监督管理局（FDA）药品监管科学进展,为我国药品监管工作提供参考和借鉴。方法通过对法规和文献进行翻译、整理与研究,介绍FDA近年来新启动的监管项目和最新进展,并分析与我国药品审评审批制度改革的关联性。结果和结论 结合我国监管实际,参考FDA最新监管科学经验,按照新监管方法和新监管工具进行梳理分类,为监管机构管理人员提供方法参考,提升监管质量和效率,推进药品监管国际化水平提升。

关键词: 美国食品药品监督管理局, 监管科学, 药品监管, 药品注册, 药品技术审评质量

Abstract: Objective To introduce the regulatory developments of U.S. Food and Drug Administration (FDA), so as to provide reference for the drug regulation in China. Methods New initiatives and their latest progress in FDA are introduced by translation and research on related regulations and documents, and the correlation to the reform of drug review and approval in China is analyzed. Results and Conclusion According to the drug regulation in China, it is suggested that experiences of drug regulation from FDA should be overviewed and classified into regulatory methods and regulatory tools, providing methodological reference to regulators, so as to improve the quality and efficiency of drug regulation, as well as the internationalization of regulatory capacities.

Key words: U.S. Food and Drug Administration (FDA), regulatory science, drug regulation, drug application, quality of the drug technical review

中图分类号:

R951
R994.11

沙明泉, 李楠楠, 夏文静, 魏群, 温宝书. 美国FDA监管科学研究进展及启示[J]. 中国药物警戒, 2022, 19(10): 1055-1059.

SHA Mingquan, LI Nannan, XIA Wenjing, WEI Qun, WEN Baoshu. Research and reflection on regulatory science developments of U.S. FDA[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1055-1059.

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美国FDA监管科学研究进展及启示

Research and reflection on regulatory science developments of U.S. FDA

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