Drug Evaluation Committee Guidance for Preparation of Electronic Common Technical Document (eCTD) (Part 1 Revised Edition) Published: April 24, 2017
Electronic Information Subcommittee
April 2017
In August last year, the Electronic Information Subcommittee published a revised version (Version 4.2) of Part 2 (from preparation to approval of eCTD) with additional information on the procedures for submitting eCTD through the electronic data system for application.
eCTD Creation Guide, Version 4.2, Gateway-compliant Edition (Release date: August 1, 2016)
In October last year, we also revised Part 4 (Case Studies) (Version 4.2).
The main revisions were made to the sections on the use of electronic 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 status of joint development (Q1.10-1 and Q2.3-2).
In April of this year, Part 3 (Technical Support) was also revised (Version 4.2).
This revision was made because we could not keep up with the updates and because the websites of these companies are well-developed and can be researched and searched.
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 eCTDs in your company.
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