通过对ICH Q系列指导原则与我国对应技术指导原则的对比研究，分析我国药品注册药学技术要求与ICH药学技术要求的主要差异。通过对公众、专家、企业进行问卷调查，摸清ICH Q系列指导原则在我国的认知和实施基础。在对比研究和问卷调查的基础上，结合ICH的要求，提出了ICH Q系列指导原则在我国实施的建议。

Through the comparative study of ICH Quality Guidelines and corresponding Chinese technical guidelines, the main differences between Chinese pharmaceutical technical requirements for drug registration and ICH technical requirements for pharmaceutical are analyzed. Through questionnaire survey to the public, experts and enterprises, the cognition and implementation basis of ICH Quality Guidelines in China are found out. On the basis of comparative study and questionnaire survey, combined with the requirements of ICH, the implementation proposals of ICH Quality Guidelines in China are put forward in this paper.

国家食品药品监督管理总局药化注册司资助项目