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 Center for Biologics …

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

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 …

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.

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 …

1 day ago · Learn the FDA's mandatory eCTD submission requirements, including key deadlines, technical standards, and the transition from eCTD v3.2.2 to v4.0 for NDAs, BLAs

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 by major health …

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 …

Learn how to plan, prepare, and publish your first successful eCTD submission with six essential steps and expert tips for a seamless process.

6 days ago · AI-driven eCTD Module 3 generation is revolutionizing CMC authoring by automating data-heavy processes, slashing drafting time by 60–70%, and minimizing errors through intelligent …