eCTD专栏 - 国家药品监督管理局药品审评中心
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 …
This eCTD Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document...
eCTD.is - home
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. …
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 …
ICH electronic Common Technical Document - eCTD v4.0
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 …
Electronic Common Technical Document (eCTD) | FDA
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 …
ICH Official web site : ICH
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 …
解读eCTD电子提交中的数据规范与标准--康茂峰
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 …
eSubmission: Projects - Europa
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 …
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 …
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