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 implementation …

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

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 version …

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 implementation progress and …

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 submission process.

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 by major health …

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

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 teams and …

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 Regional/Module 1 documents …

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 version of eCTD, …