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 …

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 …

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 …

Sep 16, 2024 · The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for …

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 …

May 19, 2025 · Recognized globally and now fully active with the release of version 4.0, eCTD provides a structured, digital framework that simplifies the process of submitting applications …

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 …

The MHRA, ECOWAS, and ECAs regions do not currently have any plans to deploy eCTD v4.0; they will follow suit once other regions have paved the way. The next five years will see rapid …

Oct 2, 2025 · The progress of the pilot makes it more likely that we might see the first real eCTD 4.0 applications being submitted in Europe before the end of this year, and the planned …