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。
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.
作者
沙明泉
李楠楠
夏文静
魏群
温宝书
SHA Mingquan;LI Nannan;XIA Wenjing;WEI Qun;WEN Baoshu(Center for Drug Evaluation,NMPA,Beijing 100022,China)
出处
《中国药物警戒》
2022年第10期1055-1059,共5页
Chinese Journal of Pharmacovigilance
基金
重大新药创制国家科技重大专项2017年度(2017ZX09101001-001-002)。
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
U.S.Food and Drug Administration(FDA)
regulatory science
drug regulation
drug application
quality of the drug technical review
