Chinese Journal of Pharmacovigilance ›› 2015, Vol. 12 ›› Issue (2): 89-91.

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QPPV and Its Implication for China's Adverse Drug Reaction Monitoring Work

PENG Li-li,SHEN Lu,DONG Duo,LIU Wei,ZHANG Hua,GUO Xue,LI Xing-ling,CHENG Gang*   

  1. Centre for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2014-07-30 Online:2015-02-08 Published:2015-07-28

Abstract: Objective To provide suggestions for china to setup and improve the Contact Person of ADR through the brief introduction of Qualified Person for Pharmacovigilance (QPPV). Methods Based on literature review, the QPPV of EU and Australia was investigated and analyzed. Results QPPV has been set up in EU and Australia, it can provide valuable practical experience for our country to establish the Contact Person of ADR. Conclusion Combing with the feature of drug safety supervision in our country and using for reference of the international experience, we should establish and complete our country's Contact Person of ADR in order to improve the level of adverse drug reaction monitoring.

Key words: EU, QPPV, the Contact Person of ADR, implication

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