Chinese Journal of Pharmacovigilance ›› 2019, Vol. 16 ›› Issue (3): 134-138.

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Explore on Safety Evaluation Mode Based on Electronic Medical Records in China

WANG Wen1, TAN Jing1, YU Chuan, WU Guizhi2, XIONG Weiyi2, DONG Duo2, SUN Xin1,*   

  1. 1 Chinese Evidence-based Medicine Center and CREAT Group, West China Hospital, Sichuan University, Sichuan Chengdu 610041, China;
    2 Center for Drug Reevaluation, NMPA, Beijing 100021, China
  • Received:2018-11-28 Revised:2020-06-28 Online:2019-03-20 Published:2019-04-17

Abstract: Electronic medical records (EMRs) may represent an important data source for drug safety evaluation, and have received wide attention. However, the framework and approaches to use EMRs for drug safety evaluation have not been well established in Chinese setting. On the basis of empirical studies, we explored framework and methods for drug safety evaluation by using EMRs. Hopefully, this paper may offer a general guidance for rigorous production and appropriate use of real-world drug safety evidences based on the data from EMRs.

Key words: electronic medical records, drug safety evaluation, real world study

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