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

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 …

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 version …

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 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).

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 …

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 …

Nov 26, 2025 · The Electronic Common Technical Document (eCTD) is a standard format for submitting regulatory information to drug regulatory agencies around the world. The latest version of eCTD, …

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 submitting …