中国药物警戒 ›› 2013, Vol. 10 ›› Issue (2): 80-83.

• 政策与法规研究 • 上一篇    下一篇

我国非处方药安全性监测的必要性探讨

夏东胜1, 田春华1,汪鳌2,宋秋洁1,李岚1,杜晓曦1   

  1. 1.国家食品药品监督管理局药品评价中心,北京100045；
    2.中国非处方药物协会,北京100191
  • 收稿日期:2012-12-26 修回日期:2016-03-09 出版日期:2013-02-08 发布日期:2016-03-09
  • 通讯作者: 杜晓曦,女,主任药师,药品不良反应监测与评价。 E-mail:duxiaoxi@cdr.gov.cn
  • 作者简介:夏东胜,女,硕士,主任药师,药品不良反应监测与评价。

The Probe into the Necessity of the Safety Monitoring of Over-the-Counter Drug in China

XIA Dong-sheng1 ,TIAN Chun-hua1 ,WANG Ao2, SONG Qiu-jie1, LI Lan1, DU Xiao-xi1   

  1. 1.Center for Drug Reevaluation, SFDA, Beijing 100045, China;
    2.China Nonprescription Medicines Association, Beijing 100191, China
  • Received:2012-12-26 Revised:2016-03-09 Online:2013-02-08 Published:2016-03-09

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摘要： 目的 探讨我国非处方药安全性监测的必要性。方法 从我国药品分类管理制度与不良反应监测现状相结合的角度,探讨我国非处方药使用及其不良反应监测面临的主要问题。结果与结论 我国药品分类管理制度亟须建立适合非处方药特点与使用的非处方药品的安全监测模式,为今后进行非处方药安全监管的深入研究奠定基础。

关键词: 非处方药, 安全, 监测, 必要性, 探讨

Abstract: Objective To probe into the necessity of the safety monitoring of OTC drug in China. Methods From the point of view of the combination of drug classification management system and adverse reaction monitoring status, discuss the main problems with the use and adverse reaction monitoring of OTC drug. Results and Conclusion It is urgent to establish a mode of drug safety monitoring which is suitable for OTC drug's characteristics and use on Chinese drug classification management system, which could lay the foundation for the further research on OTC drug safety supervision in the future.

Key words: OTC, safety, monitoring, necessity, probe into

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