Chinese Journal of Pharmacovigilance ›› 2013, Vol. 10 ›› Issue (10): 602-606.

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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

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

CLC Number: