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

The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to transfer regulatory information to regulatory agencies.

This group has developed and begun to implement the eCTD across the ICH partner and observer regions. The group has developed a change control process to monitor …

Mar 12, 2025 · The latest version of the Electronic Common Technical Document (eCTD), known as eCTD v4.0, has been finalized and is now being implemented worldwide. This updated …

Jul 23, 2025 · The Electronic Common Technical Document (eCTD) has become the global standard for regulatory submissions in the pharmaceutical industry. This format is mandated …

May 19, 2025 · In this guide, we explore what is changing in eCTD v4.0, how to navigate the transition, and the benefits and challenges life sciences companies can expect—along with …

October 4-5, 2021 eCTD Guidance and Specifications Updates – Jonathan Resnick, Division of Data Management Services & Solutions, Office of Business Informatics, CDER

eCTD (electronic Common Technical Document) is a standard format for submitting Regulatory information (such as applications) to the Health Authorities, or in this case the Prequalification …

The eCTD indexer is a free and open source (GPL v3) program to generate the xml backbones - eu-regional.xml and index.xml required for submission of registration dossiers in the eCTD …

This Controlled Vocabulary Package contains the eCTD v4.0 Code List and associated Genericode files. Note that these documents need to be used in conjunction with the …