Sep 19, 2024 · CDER and CBER are accepting new regulatory applications in eCTD v4.0 format as of September 16, 2024. More information can be found on the eCTD page. Future …

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 …

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 …

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 …

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

Nov 26, 2025 · The Electronic Common Technical Document (eCTD) is a standard format for submitting regulatory information to drug regulatory agencies around the world. The latest …

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 …

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