This document provides detailed guidance on the quality information to be included in module 2 and module 3 of the common technical document. Keywords: Common technical document (CTD), quality. ICH: M 4 Q: Common technical document for the registration of pharmaceuticals for human use - Quality - Step 5.

To avoid generating and compiling different registration dossiers, this guidance describes a format for the Quality section of the CTD that will be acceptable in all three regions.

The M4Q(R2) EWG is focusing on the revision of CTD Quality sections in Modules 2 and 3 to capture quality information for the registration and lifecycle management of pharmaceuticals for human use. The main issues to be resolved during this revision include:

参考 ich 指南： q5a ， q5d， 和 q6b 对病毒性外来因子 本节应提供病毒安全性评价研究的详细信息。 病毒评价研究应当显示生产用材料被认为是安 全的， 以及用于在制造过程中测试， 评价和清除潜在危险的方法是适当的。

2024年5月21日 · The Common Technical Document for the Registration of Pharmaceuticals for Human Use: Quality – M4Q(R1) M4Q（R1）：人用药物注册通用技术文档：药学部分（中文版：征求意见稿） 阶段5: 2002.9.12: 有: M4Q Implementation Working Group Questions & Answers (R1) M4Q执行工作组问答（R1）（中文版：征求意见 ...

In order to facilitate the implementation of the M4Q guideline, the ICH Experts have developed a series of Q&As which can be downloaded from the ICH web site: http://www.ich.org M4Q Questions & Answers History

按照 ICH 进程，本指导原则由相应的 ICH 专家工作组制定，已递交管理部门征求 意见。 在ICH 进程第四阶段，最终草案被推荐给欧盟、日本和美国的监管机构采纳。

The M4Q(R2) guideline should provide guidance on the location of information supporting multicomponent and/or complex products, such as antibody-drug conjugates, vaccines, ATMPs/Cell & Gene Therapies & Tissue Engineered Products or

When a drug substance is chiral, it should be specified whether specific stereoisomers or a mixture of stereoisomers have been used in the nonclinical and clinical studies, and information should be given as to the stereoisomer of the drug substance that is to be used in the final product intended for marketing.

This document provides additional guidance for the preparation of an application file in the common technical document - quality section (CTD-Q) format. It addresses the relationship between linked CTD-Q sections for certain parameters, such as polymorphism, impurities or …