ICH M4E在中国实施的技术考虑

Technical considerations for implementation of ICH M4E in China

ICH M4是有关药品注册申请通用技术文件(common technical document,CTD)的指导原则,是为统一ICH各成员国/地区药品注册申报资料格式而制定。ICH M4E是其中关于药物临床资料申报的格式和内容。本文通过梳理中国药品注册申报临床资料要求的历史、探讨中国实施ICH M4E的特殊考虑、分析中国实施ICH M4E过程中面临的问题以及促进措施,旨在帮助申请人按照ICH M4E的要求进一步提高药物临床资料撰写的质量,进而有利加快审评进度并推进我国药物研发和监管的全球化。

ICH M4 is the guidance on Common Technical Document(CTD)for the registration of pharmaceuticals,which is formulated to assemble all the pharmaceuticals registration application materials in a common format in ICH member states/regions.ICH M4 E describes the format and structure of drug clinical data in an application.In this article,the history of the clinical data requirements for pharmaceuticals registration in China was listed,the special considerations on ICH M4 E implemented in China were discussed,the problems that were discovered during the implementation of ICH M4 E were analyzed and appropriate solutions were proposed.It is hoped that this article could help applicants improve the quality of drug clinical registration documents in accordance with the requirements of ICH M4,and then improve review efficiency and promote the globalization of new drug development and administration in China.