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由于儿童脏器功能发育尚不完善,儿科药物临床试验开展困难及儿童用药信息、药物剂型剂量缺乏等原因,使儿童面临着比成人更大的用药安全问题,因此,对儿童用药开展安全性监测研究非常重要。本文对中美两国儿童用药安全性监测法规管理及数据报告情况进行了对比分析研究,希望能为国内儿童用药安全性监测工作提供借鉴,进一步促进儿科临床合理用药。
Due to the incomplete development of children’s organ function, difficulties in clinical trials of pediatric drugs, lack of information on children’s medication and lack of dosage forms, children are faced with more drug safety problems than adults. Therefore, safety monitoring of children’s medication Research is very important. This article conducts a contrastive analysis of laws and regulations on drug safety monitoring and reporting of data between China and the United States in the hope of providing reference for drug safety monitoring in children in China and further promoting the rational use of medicines in pediatrics.