中国药物警戒 ›› 2012, Vol. 9 ›› Issue (7): 410-412.

• 政策与法规研究 • 上一篇    下一篇

美国风险物质数据库构建经验及启示

李春潇1, 2, 李可欣2*, 武志昂1   

  1. 1 沈阳药科大学工商管理学院,辽宁 沈阳 110016；
    2 卫生部北京医院临床药理室,北京 100730
  • 收稿日期:2011-12-26 出版日期:2012-07-10 发布日期:2015-08-07
  • 通讯作者: 李可欣,女,主任药师,E-mail：kexinli6202@163.com。
  • 作者简介:李春潇,男,硕士,药品风险管理。
  • 基金资助:
    “心脑血管疾病新药临床评价技术平台研究（2008ZX09312）”课题项目

The Experience and Enlightenment of the Establishment of American Hazardous Substances Data Bank

LI Chun-xiao1, 2, LI Ke-xin2*, WU Zhi-ang1   

  1. 1 The pharmaceutical administration school of Shenyang pharmaceutical university, Liaoning Shenyang 110016, China;
    2 Department of clinical Pharmacology of Beijing Hospital, Beijing 100730, China
  • Received:2011-12-26 Online:2012-07-10 Published:2015-08-07

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摘要： 全面的药品信息数据库对于药品评价具有重要意义。美国风险物质数据库在药品信息整合与组织管理方面积累了丰富经验,为该国药品评价工作提供便利。针对我国药品信息数据库及相关方发展现状,建议我国政府借鉴美国风险物质数据库相关经验,主导构建和完善药品信息数据库,同时积极动员社会相关组织参与,从而推进我国药品评价工作。

关键词: 药品信息数据库, 安全性评价, 药品不良反应

Abstract: A comprehensive drug information database is important to drug evaluation. Hazardous Substances Data Bank is rich in the management experience of information and organization, which plays an important part in drug evaluation. On contrast with current condition of China's drug information database and related parts, it suggested the authority of the PRC taking advantage of the experience of Hazardous Substances Data Bank, playing the major role in establishment and improvement of comprehensive drug information database, involving the potential parties. The above effort will give rise to drug evaluation project at home.

Key words: drug information database, safety assessment, ADR