Drug Evaluation Committee Guidance for Preparation of Electronic Common Technical Document (eCTD) (Part 4 Revised Edition) Published: October 21, 2016
Electronic Information Subcommittee
October 2016
Revised editions of Part 1 (Basic Information) and Part 2 (From Preparation to Approval of eCTD) (Part 4.2 Gateway-compliant edition) were published in August this year, with additional information on the procedures for submitting eCTD 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.
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