摘要
目的 总结我国儿童用药临床试验期间药物警戒监管体系现状与不足,以期为进一步提升我国儿童用药临床试验期间药物警戒监管工作能力提供参考。方法 采用理论研究与比较分析法,阐述了我国临床试验期间药物警戒法规现状,总结了针对儿童用药临床试验期间药物警戒法规制定的必要性,对比了儿童用药与成人用药安全性报告审核思维的差异,对监管提出建议。结果 我国现有临床试验期间药物警戒法规多为针对整体人群,缺乏儿童用药相关法规。儿童用药临床试验期间安全性报告审核思维与成人报告差异较大,应当在制定审核标准时予以考虑。结论 我国现有儿童用药临床试验期间药物警戒监管工作需进一步加强。
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.
作者
刘文东
崔欢欢
王晓晗
苏娴
王海学
LIU Wendong;CUI Huanhuan;WANG Xiaohan;SU Xian;WANG Haixue(Centre for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国药物警戒》
2023年第9期1002-1006,共5页
Chinese Journal of Pharmacovigilance
关键词
儿童
儿童受试者
药物警戒
临床试验
新药研发
伦理委员会
药品不良反应
pediatric
children subjects
pharmacovigilance
clinical trial
new drug development
ethics committee
adverse drug reactions