摘要
创新药研发是一个探索性的研究过程,具有不同于仿制药的研发规律和研究特点,研究和审评应遵循其规律有序开展。参考FDA、欧盟发布的IND申请药学相关技术指南,结合笔者近年来的审评实践,对创新药药学研发的特点、阶段性的技术要求进行讨论,并介绍近期国内创新药审评的相关政策。
As R＆D of innovative drags is an exploratory process, the research and evaluation of innovative drugs should follow its own rules. Based on INDs review experience, referring to FDA and EMA＇s guidelines on CMC information of INDs, this article is intended to introduce CMC R＆D characteristics of innovative drugs, and discuss the phase-dependent CMC requirements for INDs.
出处
《药物评价研究》
CAS
2016年第4期664-667,共4页
Drug Evaluation Research
关键词
创新药
药学
研发特点
技术要求
innovative drugs
CMC
R＆D characteristics
technical requirements
