Chinese Journal of Pharmacovigilance ›› 2022, Vol. 19 ›› Issue (2): 176-179.
DOI: 10.19803/j.1672-8629.2022.02.13

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Problems with and suggestions about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China

LIU Min, PEI Xiaojing, WANG Haixue*   

  1. Center for Drug Evaluation National Medical Products Administration, Beijing 102488, China
  • Received:2021-05-06 Online:2022-02-15 Published:2022-02-15

Abstract: Objective To improve the quality of expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs. Methods This article was based on the questions of safety reports received by regulators over the past two years combined with the current requirements and developments of expedited reporting at home and, screened several common problems. Results Some common problems about expedited reporting of suspected unexpected serious adverse reactions during clinical trials of drugs in China were analyzed and suggestions were offered. Conclusion Personnel engaged in expedited reporting during clinical trials of drugs should have accurate understanding of the requirements of guidelines and regulations related to pharmacovigilance at home and abroad so as to better protect the safety of subjects.

Key words: clinical trials, expedited reporting, common problems, safety, suspected and unexpected serious adverse reactions

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