Drug Evaluation Committee Guide to the Preparation of Electronic Common Technical Documents (eCTD) (Part 4, Revised Edition) Published: October 21, 2016
Electronic Standard for Medical Information Expert Committee
October 2016
A revised version of Part 1 (Basic Information) and Part 2 (From Preparation to Approval of eCTD) (Part 4.2 Gateway-compliant version) was published in August this year, with additional information on the procedures for submitting eCTDs via the electronic data system for application.
Version 4.2 Gateway-compliant version
This time, Part 4 (Case Studies) has also been revised. The main revisions are the modification of the use of electronic data systems for applications (Q1.1-4, Q1.1-14, Q1.1-15, Q1.4-1, Q1.7-1, Q2.3-1, Q2.1-7) and the reorganization of the current situation regarding joint development (Q1.10-1, Q2.3-2).
Considering that the eCTD and related information will change significantly and frequently in the future, we have decided to publish this document only in electronic format.
We hope that you will use this document together with the above-mentioned revised version and find it useful in considering how to create eCTD in your company.