中国药物警戒 ›› 2010, Vol. 7 ›› Issue (10): 607-610.

• 管理及工作研究 • 上一篇    下一篇

试论中药制剂安全性问题的风险控制

吴承云1,黄文志1,郑清明1,张力2,周亚莉1, 张承绪2   

  1. 1. 四川省食品药品安全监测及评审认证中心,四川成都610017；
    2.国家食品药品监督管理局药品评价中心,北京100045
  • 收稿日期:2009-12-25 修回日期:2016-03-12 出版日期:2010-10-08 发布日期:2016-03-09
  • 通讯作者: 张承绪,男,课题负责人,药品监管。E-mail：zhangchengxu@cdr.gov.cn
  • 作者简介:吴承云,男,副主任药师,药品评价。
  • 基金资助:
    国家十一五科技支撑课题“中药上市后安全性监测与再评价标准规范研究”（2006BAI21B11）

Discuss on the Risk Control of Traditional Chinese Medicine

WU Cheng-yun1 ,HUANG Wen-zhi1, ZHENG Qing-ming1 ,ZHANG Li2, ZHOU Ya-li1 ,ZHANG Cheng-xu2*   

  1. 1.Sichuan Food and Drug Safety Monitoring and Evaluation Certification Center, Sichuan Chengdu 610017, China;
    2.Center for Drug Reevaluation, SFDA, Beijing 100045, China
  • Received:2009-12-25 Revised:2016-03-12 Online:2010-10-08 Published:2016-03-09

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摘要： 通过对相关的药品监督管理法律、法规的梳理及相关文献的查阅整理,结合我国中药制剂目前的现状,探讨中药安全性的影响因素。基于现行药品监管制度,明确各涉药机构中药安全性问题风险控制的责任及义务,阐述其风险控制方法及措施,为中药制剂安全合理应用服务。

关键词: 中药制剂, 风险控制, 药品不良反应

Abstract: This essay based on analyzing the pertinent literature, unscrambling the correlative laws and regulations of drug administration in force, and combining the situation of Traditional Chinese Medicine(TCM), The influential factors of TCM safety were discussed; as for the organizations relative to TCM, the responsibility and obligation were determined to controlling the risks from TCM, how and take what measures to decrease the risks were stated as well.

Key words: Traditional Chinese Medicine(TCM), risk control, adverse drug reaction(ADR)

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