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 Center for …

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 …

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 implementation progress and …

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 …

2 days ago · The eCTD hierarchy is a standardized, modular structure used to organize this data, streamlining the review process for regulatory bodies worldwide. This structure allows for efficient …

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.

Oct 4, 2024 · Per the FDA Data Standards Catalog, the electronic submission of eCTD v4.0 to CBER and CDER is supported for new NDA, BLA, ANDA, IND, and MFs beginning September 16, 2024. …

In this blog, Veristat’s Manager of Regulatory Operations, Angie Gray, briefly explains eCTD 4.0, how it differs from version 3.2, and how Veristat can support your organization through this important …

Major countries, such as the US, Europe, Australia, Canada, South Africa, Thailand, and Japan, are using eCTD as a standard format for submissions of documents because of numerous advantages …