中国药物警戒 ›› 2012, Vol. 9 ›› Issue (3): 146-148.

• 管理及工作研究 • 上一篇    下一篇

论我国药品不良反应监测技术工作的发展阶段

沈璐，刘巍，范燕，温庆辉，海颖，李馨龄*   

  1. 国家食品药品监督管理局药品评价中心，北京 100045
  • 出版日期:2012-03-10 发布日期:2015-08-10
  • 通讯作者: 李馨龄,男,副主任医师,中医学。E-mail:lixinling@cdr.gov.cn
  • 作者简介:沈璐，女，主管药师，药事法规。

Discussion on the Technical Development Period of Adverse Drug Reaction Monitoring in China

SHEN Lu, LIU Wei, FAN Yan, WEN Qing-hui, HAI Ying, LI Xin-ling*   

  1. Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Online:2012-03-10 Published:2015-08-10

摘要： 药品不良反应（ADR）监测工作是药品监督管理工作的特别是药品安全监管的重要前哨，是各级药品监督管理部门和卫生行政部门保证公众用药安全、促进合理用药的重要职责，同时也是一个国家药品监督管理水平和社会进步与发展水平的重要标志。在我国ADR监测工作走过20多年的发展历程之后，在新修订的《药品不良反应报告和监测管理办法》颁布实施之际，本文试图在总结过去、分析当前、展望未来之基础上，依据药品不良反应监测核心能力的逐步提升和重点转移，将我国的药品不良反应监测工作划分为初级阶段、发展阶段和成熟阶段，并得出监测工作目前已完成初级阶段建设，正迈向以深化评价能力为特征的发展阶段的结论。

关键词: 药品不良反应监测, 发展阶段

Abstract: Adverse drug reaction(ADR) monitoring is the front line of drug administration especially of drug safety administration. It is the important responsibility of government to assure the drug safe usE on the public and promote the rational use. At the same time it is the signal of the level on drug administration and social progress. After over 20 years of ADR monitoring in China, the new Regulation for the Administration of Adverse Drug Reaction Reporting and Monitoring is published and come into effect. This article reviews the past, analyses the present, prospects the future, and marks the whole ADR monitoring into three phases the primary period, the developing period and the developed period in accordance with the increasing and transfer of the key ability of ADR monitoring. We think that the current ADR monitoring practice has completed the establishment of the primary period, and now is entering the developing period whose important character is to enhance the ability of reevaluation.

Key words: adverse drug reaction monitoring, technical development period