近年我国进口药品儿童应用许可情况分析

Analysis on Imported Drugs Approved for Children in Recent Years

我国自2015年进行药品审评审批改革以来,不断完善、鼓励研发政策,逐步优化药品审评审批流程,为进口药品和儿童用药产品的上市提供了政策支持。进口药品对于满足和丰富我国儿科临床用药需求具有重要价值。该研究通过分析对比2019年以来我国批准上市的进口药品儿童应用的境内外批准情况,以更好地认识进口药品在我国的儿童用药注册现状,为进一步鼓励进口药品在我国申报儿童应用提供借鉴和参考。

Since the reform of drug evaluation and approval system in 2015,China has established various policies for imported drugs and pediatric drugs.Imported drugs are of great value in satisfying pediatric clinical needs in China.This study aimed to understand the registration situation of imported drugs for children and provide policy suggestions through analysis on imported drugs approved for children since 2019.