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 Biologics...

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

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

The eCTD format is regarded as the principal electronic submission format in EU for human medicinal products and is the only electronic format that is accepted by the EMA (except for some specified procedures) and is stepwise becoming mandatory within the Decentralised, Mutual Recognition Procedures and purely National Procedures as well dependi...

Visit www.fda.gov/ectd to find all of the relevant guidances and technical specifications for eCTD and a step-by-step guide to setting up an Electronic Submissions Gateway account.

Welcome to the Electronic Common Technical Document (eCTD): Overview and Submission Web-Based Training (WBT) course. This course will walk you through the essential steps of...

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 Package History document or the eCTD v4.0 Controlled Vocabulary ReadMe file for a detailed revision history.

Using the change control process, several topics including study report structure, lifecycle management, and consistency with the CTD are being addressed and resolved. This defined change control process ensures that the future of the eCTD is managed in a clear, harmonised manner within the ICH process.

For eCTD submissions within EU, the EU Module 1 eCTD Specification (see link below) should be used. The eCTD format is mandatory to use for all submission types related to Marketing Authorisation for products within all EU procedures (i.e. Centralised, Decentralised and Mutual Recognition Procedures).

A common technical document in electronic format. Abbreviated as eCTD. For more information, see the eSubmission website's section on eCTD.