摘要
本文梳理总结了我国化学药品和生物制品药学申报资料格式实施ICH M4Q指导原则的经验,同时结合M4Q (R1)版本实施后ICH发布的多项质量和综合性技术指导原则,就药学申报资料遵循通用技术文档(CTD)格式的具体技术要求和主要问题进行了探讨。
The experience in the implementation of ICH M4 Q in China was summarized, regarding the chemistry, manufacture & control(CMC) dossiers of chemical and biological drugs. Because ICH has developed many important quality and multidisciplinary guidelines after the implementation of ICH M4 Q(R1) version, this article discussed the specific requirements and major problems of CTD format in combination with the current technical guidelines.
作者
刘涓
周莉婷
于红
何伍
张宁
LIU Juan;ZHOU Li-ting;YU Hong;HE Wu;ZHANG Ning(Center for Drug Evaluation Rational Medical Products Administration,Beijing100022.China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2021年第22期2053-2058,共6页
Chinese Journal of New Drugs
关键词
ICH
M4Q
药学申报资料格式
通用技术文档
主要问题
ICH M4Q
format for chemistry
manufacture&control dossiers
common technical documents
major problems
