Module 1 Administrative information .......................................................................................... 1

The CTD is organised into five modules. Module 1 is region specific and Modules 2, 3, 4 and 5 are intended to be common for all regions. The CTD became the mandatory format for new drug …

The CTD consists of five modules, often presented in a triangle showing how they are connected to each other. Module 1 at the top is region-specific, and Modules 2, 3, 4, and 5 are intended to be …

Sep 8, 2022 · Celegence explains the structure of the Electronic Common Technical Document (eCTD) used for new drug and biologics submissions.

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.

The current version of the eCTD specification to be used for CTD modules 2-5 is the Electronic Common Technical Document Specification V3.2.2 (PDF). More information about the standard can be found …

As of May 2024, the Implementation Guide and Controlled Vocabulary documents were split into two different packages to enable Controlled Vocabulary Versioning. See the Implementation Guide …

Dec 21, 2025 · eCTD is based on the Common Technical Document (CTD) format developed by ICH and comprises five main modules: These are structured in a specific directory layout with XML …

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. …

This document details the requirements for the submission of eCTD electronic submissions. A separate document, covering NeeS (Non-eCTD electronic Submissions), has already been published on the …