Oct 4, 2024 · The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research (CDER) and …

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 …

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

These eCTD resources, including FDA industry guidances, submission standards, a data standards catalog, eCTD v4.0 implementation, and more, will help provide direction in the …

Jul 25, 2024 · eCTD 4.0 represents the latest evolution of an ongoing journey to make the global submission and review process more efficient, consistent, and user-friendly for publishing …

Sep 19, 2024 · Documentation, files, and links provide information on how to submit eCTD v4.0-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the …

Dec 21, 2025 · The Electronic Common Technical Document (eCTD) has become the global standard for regulatory submissions in the pharmaceutical industry. This format is mandated …

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 …

For eCTD 4.0 in Japan, clinical studies are accepted in CDISC standard using ADaM and SDTM formats, similar to the U.S., though JP requires additional keywords for the studies.