中国药物警戒 ›› 2019, Vol. 16 ›› Issue (10): 591-593.
DOI: 10.19803/j.1672-8629.2019.10.04

• ICH E2B（R3）转化与实施专栏 • 上一篇    下一篇

实施E2B（R3）对我国药品安全相关机构信息系统建设影响的研究

王青, 任韡, 杨吉江   

  1. 清华大学信息技术研究院,北京 100084
  • 收稿日期:2019-10-24 修回日期:2019-10-24 出版日期:2019-10-20 发布日期:2019-10-24
  • 作者简介:王青,男,博士,副研究员,计算机辅助决策技术与大数据挖掘技术。
  • 基金资助:
    国家药品不良反应监测中心资助项目（2018IX001）：E2B数据标准研究

Impact of E2B(R3) Implementation on Information System Construction in Drug Safety Related Institutions in China

WANG Qing, REN Wei, YANG Jijiang   

  1. Research Institute of Information Technology, Tsinghua University, Beijing 100084, China
  • Received:2019-10-24 Revised:2019-10-24 Online:2019-10-20 Published:2019-10-24

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摘要： 目的 探讨我国在药品安全监管领域实施E2B（R3）后,对未来相关机构开展药物警戒以及药品不良反应监测与评价等药品安全工作的信息系统建设产生的影响。方法 分析E2B(R3)实施的过程和范围,探讨实施E2B（R3）对我国药品监管机构、医疗机构、相关企业在各自信息系统建设过程中可能产生的影响和挑战。结果与结论 E2B(R3)的实施是我国药品安全监管领域的重要举措,其实施对我国药品监管机构、医疗机构、相关企业的信息系统建设都产生了系列挑战,各相关机构需要在总体规划、系统建设、标准兼容等多个方面采取相应的应对措施。

关键词: E2B(R3), 个例安全性报告, 药物警戒, 信息系统

Abstract: Objective To explore the impact of implementing E2B (R3) in the field of pharmaceutical supervision on the development of information systems for pharmacovigilance and ADR monitoring by related institutions in the future. Methods The process and scope of E2B (R3) implementation were analyzed, and the possible impact of E2B (R3) implementation on China's regulatory bodies, medical institutions and related enterprises in the construction of their respective information systems was explored. Results & Conclusion The implementation of E2B (R3) is an important measure in the field of pharmaceutical supervision in China. It has posed a series of challenges to the information system construction of regulatory agencies, medical institutions and related enterprises. Those institutions need to take corresponding measures related to overall planning, system construction and standard compatibility.

Key words: E2B(R3), ICSR, pharmacovigilance, information system

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