Chinese Journal of Pharmacovigilance ›› 2014, Vol. 11 ›› Issue (9): 561-563.

Previous Articles     Next Articles

Study on the Evaluation for Quality of Adverse Drug Reaction Reports in China

LIU Wei, LI Xin-lin CHEN Gang, SHEN Lu, DONG Duo, LIU Cui-li, WANG Ya-li   

  1. Center for Drug Reevaluation, CFDA, Beijing 100045, China
  • Received:2014-06-05 Revised:2016-02-03 Online:2014-09-08 Published:2016-03-02

Abstract: ObjectiveTo review the progress of the evaluation for the quality of the adverse drug reactions(ADR) in China. MethodsProgress of the evaluation for the quality of the ICSRS and the ADR database in China were reviewed and summarized. ResultsBy the evaluation for the quality of the ICSRS, the detail problems such as spelling could be found. By the evaluation for the quality of the ADR database, the macroscopic problems such as the method and the trend could be found. They complement each other and play a positive role for the healthy development of ADR monitoring. ConclusionThe quality of ADR report is an important content of the ADR monitoring, so it is very necessary to establish scientific and operable evaluation system and methods.

CLC Number: