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 …

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 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 …

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 …

Electronic Common Technical Document (eCTD) submissions have transformed sponsor companies' interactions with global health authorities. Over the past two decades, eCTDs …

This course will walk you through the essential steps of submitting electronic submissions to the Center for Drug Evaluation and Research (CDER), and can serve as a resource for questions …

eCTD is an electronic format used for submitting applications, amendments, supplements, and reports to drug-related authorities. It provides detailed information on medicinal products to …