中国药物警戒 ›› 2012, Vol. 9 ›› Issue (1): 26-28.

• 管理及工作研究 • 上一篇    下一篇

我国疫苗风险管理模式探讨

王亚丽，董铎，杜晓曦*   

  1. 国家药品不良反应监测中心，北京100045
  • 收稿日期:2011-04-25 出版日期:2012-01-10 发布日期:2015-08-10
  • 通讯作者: duxiaoxi@cdr.gov.cn
  • 作者简介:王亚丽，女，博士，药品不良反应监测。
  • 基金资助:
    科技部课题资金资助项目（2009ZX10004-806）

Vaccine Risk Management in China

WANG Ya-li, DONG Duo, DU Xiao-xi*   

  1. Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2011-04-25 Online:2012-01-10 Published:2015-08-10

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摘要： 药品风险管理是围绕药品安全性问题开展的，通过上市前研究或上市后不良反应监测，完成药品风险评估、风险控制、风险审核和风险沟通的系统过程。疫苗作为一种特殊的药品，其风险管理尤为重要。本文分析了我国疫苗不良反应监测的现状及存在的问题，并参考国际先进经验，对我国疫苗风险管理模式进行了探讨。

关键词: 疫苗, 风险管理

Abstract: Drug risk management is a process around drug safety, which including risk evaluation, risk control, risk review and risk communication, through premarketing study or postmarketing adverse drug reaction monitoring.Vaccine risk management is important, because vaccine is a special drug. In this paper, the situation and problems about adverse vaccine reaction monitoring in our country were analyzed. And the risk management in our country was researched referencing international best practices.

Key words: vaccine, risk management