电子通用技术文档（eCTD）是对通用技术文档（CTD）的一种电子化呈现和管理方式，通过可扩展标记语言（XML）技术将基于CTD文件结构和eCTD技术规范的文件加以组织，并用于药品注册申报和审评的一种注册文件技术格式。 eCTD使申报资料编制、申报、受理、审评、全生命周期管理和档案存储更加便捷经济，既保障了资料的申报质量，又提高了审评效率，更重要的是使申报资料的格式、内容及标准要求保持全球通用性和一致性。

This eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document...

The eCTD indexer is a free and open source program to generate the xml backbones - eu-regional.xml and index.xml required for submission of registration dossiers in the eCTD format. Use of this program requires knowledge of the guidelines linked below and a (very) basic understanding of XML.

The eCTD format is regarded as the principal electronic submission format in EU for human medicinal products and is the only electronic format that is accepted by the EMA (except for some specified procedures) and is stepwise becoming mandatory within the Decentralised, Mutual Recognition Procedures and purely National Procedures as well dependi...

See the Implementation Guide Package History document or the eCTD v4.0 Controlled Vocabulary ReadMe file for a detailed revision history. The latest version of the eCTD v4.0 Implementation Guide (v1.6) and eCTD v4.0 Controlled Vocabulary Package (v1.0.2) documents were endorsed by the ICH Assembly in May 2024.

2024年10月4日 · The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and...

The Electronic Common Technical Document (eCTD) allows for the electronic submission of the Common Technical Document (CTD) from applicant to regulator. While the table of contents is consistent with the harmonised CTD, the eCTD also provides a harmonised technical solution to implementing the CTD electronically.

2024年11月7日 · ectd技术规范由ich发布，目前最新版本为ectd 4.0。该规范详细定义了xml文件的架构、元数据要求和文件命名规则。 xml架构：ectd 4.0采用了更为灵活的xml架构，支持更多的元数据和复杂的数据结构。

In other words, an eCTD is the submission of PDF documents, stored in the eCTD directory structure, accessed through the XML backbone and with the files integrity guaranteed by the MD5 Checksum. The current version of the eCTD specification to be used for CTD modules 2-5 is the Electronic Common Technical Document Specification V3.2.2 (PDF).

The Module 1 eCTD Backbone File (us-regional.xml) includes administrative information and information for each file submitted in Module 1. The backbone file contains an XML element named