Drug Evaluation Committee Guide to the Preparation of Electronic Common Technical Documents (eCTD) (Part 3, Revised Edition) Published: April 10, 2017
Electronic Standard for Medical Information Expert Committee
April 2017
Electronic Standard for Medical Information Expert Committee In August last year, the Japan Pharmaceutical Manufacturers Association (JPMA) published a revised version of Part 2 (from preparation to approval of eCTD) (Edition 4.2: Gateway-compliant version), which includes additional information on procedures when submitting eCTD via the electronic data system for application.
Guide to Creating eCTD, Version 4.2, Gateway-compliant Edition (Published: 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 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).
The main revision in Part 3 this time is in the section "Chapter 7: Rules, Contractors", where we have removed relevant information from the guide, since the eCTD has become widely used and the latest information can be easily found on the Internet by the relevant tools and contractors.
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 make use of this document together with the above-mentioned revised version, and that you will find it useful in considering how to create your own eCTD.