Status and thinking of Parmacovigilance regulatory system during clinical trials of the pediatric drug in China

doi:10.19803/j.1672-8629.20220535

Abstract

Abstract: Objective To summarize the current status of pharmacovigilance regulatory system during clinical trials of the pediatric drug in China, in order to provide reference for further improving of the pharmacovigilance regulatory capacity during the clinical trials of pediatric drug in China. Methods Theoretical analysis and comparative analysis were used to summarize the current status of pharmacovigilance regulations during clinical trials in China, compare the differences of drug safety reports review strategies between children and adults, and provide suggestions for the regulatory authority. Results Most of the current pharmacovigilance regulations during clinical trials in China are aimed at the overall population, and there are no regulations related to pediatric drug. There are significant differences of the drug safety reports review strategies between children and adults, and should be considered when developing review standards. Conclusion The pharmacovigilance regulatory system during clinical trials needs to be further refined for the pediatric drug.

Key words: pediatric, children subjects, pharmacovigilance, clinical trial, new drug development, ethics committee, adverse drug reactions

CLC Number:

R954

LIU Wendong, CUI Huanhuan, WANG Xiaohan, SU Xian, WANG Haixue. Status and thinking of Parmacovigilance regulatory system during clinical trials of the pediatric drug in China[J]. Chinese Journal of Pharmacovigilance, 2023, 20(9): 1002-1006.

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