ICH Project ICH M8 eCTD v4.0 Notification Overview Briefing
August 28, 2017
To establish common specifications for electronic submission forms, ICH M8 has continued to review the new specifications.The new specification (eCTD v4.0) reached Step 2 in November 2014 and Step 4 in December 2015, and the ICH eCTD v4.0 Implementation Guide has been published on the official ICH website (ESTRI page).
On July 5 of this year, notifications related to eCTD v4.0, as discussed by the ICH, were issued in Japan.
At this briefing, PMDA provided an explanation focused on an overview of the “eCTD v4.0 Implementation Guide” to aid in understanding the content of the notifications. Additionally, given that there is a several-year preparation period before Japan begins accepting eCTD v4.0 submissions, we offered proposals regarding preparations for implementation within pharmaceutical companies.
Over 190 industry representatives attended this briefing session, demonstrating the high level of interest among participants.
The program, presentation schedule, and presentation materials for this briefing session are attached below and can be viewed directly. Please note that unauthorized copying or reproduction of the attached materials posted on this website is prohibited.
Date, Time, and Location
| Date and Time | Location |
|---|---|
| Tuesday, August 8, 2017, 1:30 PM – 4:30 PM | Nihonbashi Life Science Building, 2nd Floor, Conference Room 201 |
Information and Program
Event Announcement and Program (115 KB)
Presentation Materials
| Presentations | Speakers |
|---|---|
| Taku Watanabe (M8 Rapporteur, NIH) | |
| 02_Interpreting the eCTD v4.0 Notification: From an Industry Perspective (1,653 KB) | Kayoko Ichikawa (Japan Pharmaceutical Manufacturers Association, M8 Topic Leader) |
| 03_Corporate Preparations for eCTD v4.0 Implementation (475 KB) | Ryoichi Hiruma (Japan Pharmaceutical Manufacturers Association, M8 Expert) |