Drug Evaluation Committee Guidance for Preparation of Electronic Common Technical Document (eCTD) (Part 3 Revised Edition) Published: April 10, 2017
Electronic Information Subcommittee
April 2017
In August last year, the Electronic Information Subcommittee published a revised version of Part 2 (from preparation to approval of eCTD) (Edition 4.2: Gateway-compliant version), which includes 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).
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).
The main revision in Part 3 this time is in the section "Chapter 7: Rules, Contractors", where relevant information has been removed from the guidance, as the widespread use of eCTD has made it easy for relevant tools and contractors to look up the latest information on the Internet.
Considering that the eCTD and related information will change significantly and frequently in the future, we have decided to make it available only in electronic format.
We hope that you will use this guide together with the above-mentioned revised version to help you consider how to create your own eCTD.
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