Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission to the U.S. Food and Drug Administration (FDA). This guidance presents the agreed

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.

2004年1月2日 · 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.

2021年1月20日 · m4包含了药品全生命周期内，安全性信息、有效性信息和质量可控性方面的研究信息，按照粒度文件持续更新，保证了可溯源性和完整性。 下面我们分别将M4通用技术文档的五个模块与80号文进行详细的对比。

The sequence of M4 Common Technical Document for the Registration of Pharmaceuticals for Human Use is: M4 - Organisation of Common Technical Document M4 Quality - Quality overall summary of Module 2 and Module 3: Quality M4 Safety - Nonclinical Overview and Nonclinical Summaries of Module 2 and Organisation of Module 4

督管理局组织制定了《m4：人用药物注册申请通用技术文档》（以下简称m4）模块一文件：行政文件和药品信息，现予以发布。 自2019年7月1日起，对2018年第10号

The guidance for industry issued in November 2000 on preparing the CTD was divided into four separate documents: (1) M4: Organization of the CTD, (2) M4: The CTD — Quality, (3) M4: The...

This is one in a series of guidances that provide recommendations for applicants preparing the Common Technical Document for the Registration of Pharmaceuticals for Human Use (CTD) for submission...

自2019年7月1日起，对2018年第10号公告规定情形的药品注册申请，申请人应按照m4模块一文件要求提交资料。 同时，国家药品监督管理局组织翻译了M4指导原则全文，形成了中文版，一并予以发布。

通用 2001年6月，日本厚生劳动省颁布了新药上市申请的CTD指南 （JP-CTD）:PMSB/ELD Notification No.899。2017年7月颁布的 PSEHB/ELD Notification No.0705/4修订了 JP-CTD相关章节。要求模块 二需要提交GAIYAO，并要求翻译成日文，表格除外。对于新的赋形