化学创新药审评中基于ICH Q11的考虑

Considerations for the technical review of new drugs based on ICH Q11

国际人用药品注册技术协调会(ICH)Q11是原料药开发和生产的技术指导原则,系统阐述了原料药工艺开发的基本方法和起始原料的选择原则;ICHQ11问答文件进一步阐述了选择起始原料的具体要求。本文参考ICHQ11及问答文件的要求,围绕创新药药学研究的阶段性规律,讨论化学创新药技术审评中基于ICHQ11的考虑。

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)Q11 is the technical guideline for the development and manufacture of drug substances,which systematically illustrates the principles of process development and selection of starting materials.ICH Q11 Q&A document further elaborates the specific requirements for the selection of starting materials.This paper discusses the consideration based on ICH Q11 in the technical review of chemical innovative drugs with respect to the requirements of ICH Q11 and the Q&A document,and further discusses the general considerations of ICH Q11 on the technical review of new drugs focusing on the periodic rules regarding pharmaceutical research of innovative drugs.