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PDF(5718 KB)
PDF(5718 KB)
关于药品监管机构数据完整性规范/指南的解读
Interpretation of Data Integrity by Drug Regulatory Agencies
目的 了解药品监管机构在数据完整性方面要求的新动态。方法 解读国内外主要药品监管机构数据完整性规范/指南。数据完整性作为药品质量体系中最关键的内容,药品监管机构均出台了相应的规范/指南对其进行重点强调。规范/指南旨在提供有关数据管理和完整性的关键原则的基本概述,并且根据审查机构的反馈包括监管机构、企业提供的经验等,规范/指南定期更新、修订和审查。结果与结论 本文总结了6个国内外主要药品监管机构数据完整性规范/指南的阐述角度和侧重内容,对部分概念进行了解释区分,有助于对规范/指南的理解和应用。
OBJECTIVE To understand the new development of data integrity by drug regulatory agencies. METHODS Data integrity by drug regulatory agencies in domestic and abroad were interprated in this paper. Data integrity is critical elements of the pharmaceutical quality system, and drug regulatory agencies have issued practise /guidance on data integrity to highlight it. Practise /guidance provide a basic overview of key principles relating to data management and integrity which are regularly updated, revised and reviewed based on the feedback from review agencies, including the experience provided by various regulatory agencies and enterprises. RESULTS and CONCLUSION This paper summarizes the individual and common issues of the six major data integrity practise /guidance, explains and differentiates some concepts, which helps to understand and apply practise /guidance.
药品监管机构 / 数据完整性 / 规范 / 指南 {{custom_keyword}} /
drug regulatory agency / data integrity / practise / guidance {{custom_keyword}} /
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