境外已批准用于儿科人群品种的数据外推策略及一般考虑

Data extrapolation strategy and general consideration for the products approved for pediatric use oversea

境外已批准用于儿科人群的品种采用数据外推策略申请批准中国儿科应用的申报数量逐年增加。为避免不必要的儿科重复研究,进一步规范数据外推策略在儿科用药中的应用,尽快满足我国儿科临床需求。本文针对境外已批准用于儿科人群品种的数据外推策略和一般考虑进行讨论,同时,对申报资料需要注意的问题给予建议。

The number of applications for the drugs approved for pediatric use oversea that apply to obtain the approval in China using data extrapolation strategy is increasing.In order to avoid unnecessary duplication of pediatric clinical trials,and to meet the needs of pediatric drugs as soon as possible,this article discusses the data extrapolation and clinical trials strategy for this kind of applications,and gives suggestions on the application materials and issues that should be considered.