The practice and consideration of pharmacovigilance during clinical trials in China

doi:10.19803/j.1672-8629.20220242

Abstract

Abstract: Objective To compare the construction of pharmacovigilance between United States and European Union, especially on the monitoring and managing of the safety signal; to meditating the future development direction of pharmacovigilance of China during the clinical trial. Methods The organizational framework, law and regulation system, the concept and management of safety signal for the implementation of pharmacovigilance between United States and European Union were compared, combined with the implementation experience of relevant work in China, suggestions for improving the level of pharmacovigilance during clinical trials in China were put forward. Results and Conclusion The pharmacovigilance system of United States and European Union are relatively perfect, the monitoring of safety information and mechanism of risk management are relatively mature. The pharmacovigilance system of clinical trial of China has been basically in place. The advance foreign experience can be referenced and through strengthening the law and regulation and organization system, carrying out focusing monitoring to improve the level of informationization to improve the level of pharmacovigilance of clinical trial in China.

Key words: clinical trial, pharmacovigilance, United States, European Union, adverse drug reaction

CLC Number:

R951
R994.11

CUI Huanhuan, PEI Xiaojing, LI Yanrong, LIU Wendong, WANG Haixue, LAN Gongtao, WANG Tao. The practice and consideration of pharmacovigilance during clinical trials in China[J]. Chinese Journal of Pharmacovigilance, 2022, 19(10): 1050-1054.

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