Chinese Journal of Pharmacovigilance ›› 2017, Vol. 14 ›› Issue (5): 295-297.

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Ideas on Trend of ADR Monitoring Model in China

SHEN Lu, LIU Wei, GUO Xue, PENG Li-li, KONG Fan-yao, LI Xin-ling*   

  1. Center for Drug Reevaluation,CFDA, Beijing 100045, China
  • Received:2017-07-12 Revised:2017-07-12 Online:2017-05-20 Published:2017-07-12

Abstract: Objective To research and explore the trend of post-marketing pharmacovigilance in China. Methods The status analysis method was adopted, in view of the existing problems, the trend of post-marketing pharmacovigilance in China was conceived. Results In view of the uneven quality reports,corporate responsibility not in position, the main channel of medical institutions advantage not obvious,and other current situations,this article suggested that we should strengthen the existing ADR monitoring system, establish national ADR monitoring sentinel union, study data source cooperation, train and inspect enterprise, upgrade PSUR model, research on enterprise drug safety monitoring and evaluation system, and other methods to constantly deepen work of the post-marketing pharmacovigilance. Conclusion It would be the inevitable trend of post-marketing pharmacovigilance in China to constantly strengthen corporate responsibility, enhance the ability of enterprise, implementing the responsibility of enterprise, and raise up the monitoring system of their own ability of drug safety monitoring and evaluation.

Key words: adverse drug reaction, monitoring model, development trend

CLC Number: