美国FDA生物研究监查检查体系对我国的启示

doi:10.11669/cpj.2022.04.013

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摘要目的研究美国FDA生物研究监查检查体系,并分析我国药物研发检查中存在问题,为完善我国药物研发检查制度提供政策建议。方法通过检索美国生物研究监查检查体系的法规指南和研究文献,收集FDA网站上公布的生物研究监查检查体系财政年度工作情况报告,对法律法规、指南依据、检查程序、检查类型、检查要点和常见的检查缺陷等方面进行研究。结果美国生物研究监查检查体系拥有一套完整的指南体系作为指导,由专业化的检查员队伍执行检查,并构建了内部信息平台eNSpect辅助检查员的检查。不同类型的检查划分清楚,检查要点明确,并及时发布年度检查情况以及常见的检查缺陷。结论建议我国从建立完善的药物研发检查指南体系、加强检查员队伍建设、构建完善内部信息平台3个方面进行完善。

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	臧克承
	杜怿
	邵蓉

关键词 ：美国食品药品监督管理局, 生物研究监查, 检查体系, 研发检查

Abstract：OBJECTIVE To study the FDA bioresearch monitoring inspection system and the problems in China's drug research inspections. METHODS This article studied the laws and regulations, guideline basis, inspection procedures, inspection types, inspection points and common inspection defects. First, we searched the regulatory guidelines and research literature of the bioresearch monitoring inspection system, then we collected the fiscal year work status reports of the bioresearch monitoring inspection system published on the FDA website. RESULTS The bioresearch monitoring inspection system has a complete set of guidelines as a guide, a specialized team of inspectors to perform inspections, and an internal information platform, eNSpect, to assist inspectors in their inspections. Different types of inspections are clearly delineated, inspection points are clearly defined, and annual inspections as well as common inspection defects are released in a timely manner. CONCLUSION It is suggested that China should establish a perfect drug development inspection guideline system, strengthen the inspector team, and construct internal information platform.

Key words： FDA bioresearch monitoring inspection system research inspection

收稿日期: 2021-05-01

PACS:

R95

基金资助:2015年度国家社科基金重大项目资助(15ZDB167)

通讯作者: * 邵蓉,女,教授,博士生导师研究方向:医药政策与法规 Tel:(025)86185287

作者简介: 臧克承,男,博士研究生研究方向:医药政策与法规

引用本文:

臧克承, 杜怿, 邵蓉. 美国FDA生物研究监查检查体系对我国的启示[J]. 中国药学杂志, 2022, 57(4): 321-326. ZANG Ke-cheng, DU Yi, SHAO Rong. Research on FDA Bioresearch Monitoring Inspection System and Its Enlightenment to China. Chinese Pharmaceutical Journal, 2022, 57(4): 321-326.

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http://journal11.magtechjournal.com/Jwk_zgyxzz/CN/10.11669/cpj.2022.04.013 或 http://journal11.magtechjournal.com/Jwk_zgyxzz/CN/Y2022/V57/I4/321

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