儿童用化学药品改良型新药2.2类临床试验申请与审评情况分析及立题合理性关注点

Analysis of Application and Review of 2.2 Category Improved New Chemical Drugs for Pediatric and Concerns on the Reasonableness of Its Proposal

提供安全、有效、质量可控且适于不同年龄阶段患儿使用的药品是儿童用药开发的目标。在已知活性成分药品基础上优化具有明显儿童临床优势的改良型新药是拓展药品儿童应用的常见选择。该研究基于2016年3月4日至2022年6月30日药品审评中心受理的2.2类改良型新药临床试验申请信息,介绍了该类别药品的申报与审评情况,并梳理了立项通过和立项未通过的申报项目情况,汇总了立题合理性的关注点,以期为儿童用化学药品改良型新药2.2类临床试验申报提供参考。

The goal of pediatric drug development is to provide safe,effective,quality controllable and suitable for children of different ages.It is common to expand pediatric drug applications to optimize improved new drugs with obvious clinical advantages based on drugs with known active ingredients.Based on investigational new drug(IND)application information accepted by the Center for Drug Evaluation from March 4,2016 to June 30,2022,this paper introduced the application and review of 2.2 category improved new chemical drugs for pediatric.Meanwhile,the application items approved and failed were sorted out,and the concerns of assessment to the purpose of the project were discussed to provide a reference for the application of 2.2 category improved new drugs.