中国药物警戒 ›› 2013, Vol. 10 ›› Issue (10): 602-606.

• 政策与法规研究 • 上一篇    下一篇

我国非处方药与不良反应监测的政策对比及启示

夏东胜,王春婷,刘翠丽,汤韧,范燕,徐帅,田春华*   

  1. 国家食品药品监督管理局药品评价中心,北京 100045
  • 收稿日期:2013-07-02 修回日期:2016-03-09 出版日期:2013-10-08 发布日期:2016-03-09
  • 通讯作者: 田春华,女,副主任药师,非处方药与药品不良反应技术评价。E-mail: tianchunhua@cdr.gov.cn602
  • 作者简介:夏东胜,女,主任药师,非处方药与药品不良反应技术评价。

A Comparative Resea rch and Enlightenment on Policies about Over-the-Counter Drug and Adverse Drug Reaction Monitoring in China

XIA Dong-sheng ,WANG Chun-ting ,LIU Cui-li, Tang Ren, FAN Yan ,XU Shuai ,TIAN Chun-hua*   

  1. Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2013-07-02 Revised:2016-03-09 Online:2013-10-08 Published:2016-03-09

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摘要： 目的 加强非处方药的安全监测,保障非处方药的安全性。方法 通过对目前我国非处方药与不良反应监测相关政策的对比研究与分析,从中获得对非处方药安全性监测的启示。结果与结论 建议我国在政策层面依据非处方药特点而建立非处方药不良反应监测的相关制度和措施。

关键词: 非处方药, 不良反应, 监测, 政策, 对比, 启示

Abstract: Objective To strengthen the safety monitoring of Over-the-Counter(OTC) drug and ensure the safety of OTC drug. Methods Through the comparative research and analysis on policies about OTC drug and adverse drug reaction monitoring at present in our country, we could get the enlightenment about safety monitoring of OTC drug. Results and Conclusion To advise that we should establish drug safety monitoring system and measures on OTC drug in the aspect of policy according to the characteristics of OTC drug.

Key words: OTC, adverse drug reaction, monitoring, policy, comparison, enlightenment

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