《创新药(化学药)Ⅲ期临床试验药学研究信息指南》解读

Interpretation of Guidance on CMC Study of Investigational New Chemical Drug Applications for Phase Ⅲ Clinical Trial

为鼓励和促进国内制药企业的创新药物开发,国家药品监督管理局于2018年3月正式发布了《创新药(化学药)Ⅲ期临床试验药学研究信息指南》。本文结合该指南的起草过程,充分考虑创新药研发的特点,对指南进行详细解读,以方便申请人在创新药物研发过程中更好地理解相关技术要求。

A guidance on CMC Studies of investigational new chemical drugs for phaseⅢclinical trials was issued by NMPA on March 2018,in order to encourage and promote Chinese pharmaceutical enterprises developing investigational new chemical drugs.This paper provides a detailed interpretation of the guidance,combined with the drafting process of the guidance and fully considering the characteristics of new drug development.It is the aim of this paper to help applicants getting a better understanding of the chemical and pharmaceutical quality requirements in different state of development/clinical phase.