Guidance on the organisation of the information to be presented in registration applications for new pharmaceuticals (including biotechnology-derived products). Keywords: Common technical document (CTD), data format.

M4 : The Common Technical Document. The agreement to assemble all the Quality, Safety and Efficacy information in a common format (called CTD - Common Technical Document ) has revolutionised the regulatory review processes, led to harmonised electronic submission that, in turn, enabled implementation of good review practices.

M4 : The Common Technical Document 通用技术文件; M5 Data Elements and Standards for Drug Dictionaries 药物词典的数据要素和标准; M6 Gene Therapy 基因治疗; M7 Genotoxic Impurities 遗传毒性杂质; M8 Electronic Common Technical Document (eCTD) 电子通用技术文件

This guidance replaces two FDA guidance documents, the 2001 guidance for industry M4 Organization of the CTD and the 2005 Granularity Document Annex to M4 Organization of the CTD.

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

2024年5月21日 · M4 (R4): Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use M4（R4）：人用药物注册通用技术文档的组织（中文版：征求意见稿）

To avoid the need to generate and compile different registration dossiers, this guideline describes a format for the Common Technical Document that will be acceptable in all three regions.

M4为 CTD （The Common Technical Document），即通用技术文件，由4部分文件组成： M4 (R4)， M4Q (R1)， M4S (R2) 和 M4E (R2)。 CTD很大程度上改变了监管审查流程，促进了电子提交方式（即 eCTD）的发展，有助于 GRP （good review practices）的实施。 对于行业而言，可满足申请机构同时提交给不同ICH监管机构的需求，消除了不同地区申报资料格式的不统一，加速申报进度。 CTD分为五个模块。 模块 1 各个国家/地区都有特定要求，模块 2、3、4 和 5 通 …

第一部分 M4的基本概念 2 ICH指导原则综合性学科（Multidisciplinary） 中第四部分通用技术文件（Common Technical Document），简称M4 CTD。M4文件包含了质量 （Quality）、安全（Safety）和有效性（Efficiency） 部分。report-summary-overview,呈现了一个标准 的金字塔结构。

Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and has been subject to consultation by the regulatory parties, in accordance with the ICH...