儿科药物临床试验国内外相关法规解读与思考

摘要

目前我国很多药品说明书中尚缺乏完善的儿童用药处方信息,儿科药物临床试验是有效解决该问题的有效途径之一.国内对儿科药物临床试验的指导原则尚在进一步探索中.本文综述了欧盟、美国、ICH对于儿科药物临床试验的管理法规及其操作办法,希望对有意在国内进行儿科药物临床试验的研究人员提供参考.%The information for pediatric use of medicinal products in current labelings is limited. One of the effective ways to solve the problem is to carry out clinical trials in pediatric population. The domestic guidelines on clinical trials of medicinal products in pediatric population are still under exploration. This article reviews the management regulations and operation procedures of European Union, the United States, and ICH on clinical trials of pediatric drugs, hoping to provide reference for researchers who are interested in pediatric clinical trials.