Drug Evaluation Committee Guide to the Preparation of Electronic Common Technical Documents (eCTD) (Part 1, Revised Edition) Published: April 24, 2017
Electronic Standard for Medical Information Expert Committee
April 2017
Electronic Standard for Medical Information Expert Committee In August last year, JACPA published a revised Part 2 (from preparation to approval of eCTD) (Version 4.2), which includes additional information on the procedures for submitting eCTD through the electronic data system for application.
Guide to Creating eCTD, Version 4.2, Gateway-compliant Edition (Published: August 1, 2016)
In October last year, Part 4 (Case Studies) was also revised (Version 4.2).
The main revisions were made to the sections on the use of electronic application data systems (Q1.1-4, Q1.1-14, Q1.1-15, Q1.4-1, Q1.7-1, Q2.3-1, and Q2.1-7) and to reorganize the current situation regarding joint development (Q1.10-1 and Q2.3-2).
In addition, Part 3 (Technical Support) was also revised (Version 4.2) in April of this year.
This revision was made because it was not possible to keep up with the updates of the websites of outsourcing vendors and CROs and their outsourcing services related to eCTD preparation, and because the websites of these companies are well-developed and can be researched and retrieved through searches and other means.
Part 1 (Basic Information) has also been revised and published as Version 4.2, mainly updating information related to notices and administrative communications. This revision will be the last update of the eCTD Creation Guide based on eCTD v3.2.2. We hope that you will make use of this document together with the above-mentioned revised editions (Parts 2 to 4), and that you will find it useful in considering how to create your own eCTDs.