研发儿科人群用药策略的借鉴和审评思考  

Investigation strategy and evaluation consideration of medicinal products in the pediatric population

作　　者：陈颖[1] 鲁爽[1] CHEN Ying;LU Shuang(Center for Drug Evaluation,China Food and Drug Administration,Beijing 100022,China)

机构地区：[1]国家食品药品监督管理总局药品审评中心,北京100022

出　　处：《中国临床药理学杂志》2018年第19期2366-2371,2375,共7页The Chinese Journal of Clinical Pharmacology

摘　　要：儿科人群用药一直以来受到我国乃至全世界主管当局的重视。本文主要针对欧美日等主要国家或者地区对于儿科人群用药的上市许可相关政策以及我国药审实操等进行介绍,并对比我国目前相关监管策略,以期为科学研发药物提供参考、为儿科人群提供更多用药选择。Objective Medicinal products in the pediatric population have always been taken seriously by Chinese and even worldwide regula- tory authorities. This article mainly introduces the relevant policies for the marketing approval of pediatrics in major countries or regions, such as Europe, the United States and Japan, as well as the practice of drug evaluation in China, and compares the current relevant regulatory strate- gies in China so as to provide reference for scientific development of drugs, and to provide more drug options for pediatric population.

关 键 词：儿科用药研发 临床试验 监管策略 审评实践 

分 类 号：R97[医药卫生—药品]