ICH Project ICH M8 eCTD v4.0 related notification overview information session
Aug 28, 2017
ICH M8 has continued to study new specifications in order to achieve a common specification for electronic application forms. 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 is available on the official ICH website (ESTRI page).
On July 5 of this year, a series of notifications related to the eCTD v4.0 discussed in the ICH were issued in Japan.
In this briefing session, PMDA explained mainly the outline of the "eCTD v4.0 Implementation Guide" to support understanding of the contents of the notifications, and also provided suggestions on how to prepare for the operation within pharmaceutical companies, as there are several years of preparation before the eCTD v4.0 acceptance starts in Japan.
This briefing session was attended by more than 190 company representatives, indicating the high level of interest among the participants.
The program, presentation timetable, and presentation materials for this briefing are attached below as files for direct viewing. Unauthorized copying or reproduction of the contents of the attached files, which will be posted on this website, is prohibited.
Date, time and place
| Date and Time | Location |
|---|---|
|
Tuesday, August 8, 2017, 13:30-16:30 |
Conference Room 201, 2nd Floor, Nihonbashi Life Science Building |
Information and Program
Lecture Materials
| Presentation | Speaker |
|---|---|
|
Taku Watanabe (M8 Rapporteur, Pharmaceuticals and Medical Devices Agency) |
|
|
02_eCTD v4.0 Notification Interpretation from a company's perspective (1653KB) |
Kayoko Ichikawa (M8 Topic Leader, Japan Pharmaceutical Manufacturers Association) |
|
Ryoichi Hiruma (M8 Expert, Japan Pharmaceutical Manufacturers Association) |
|
The End