ICH Project ICH M8 eCTD v4.0 Revision Notice Briefing Session
Jun 10, 2020
ICH M8 has continued to study new specifications for eCTD in order to achieve a common specification for electronic application forms.
In response to the issuance of the "Revision of "Application for Approval by Electronic Common Technical Document (eCTD)" (No. 0219-1) dated February 19, 2020 by the Pharmaceutical Affairs Council of Japan, a briefing session was held.
In this briefing session, with the purpose of supporting the understanding of the notice, the PMDA explained the main points of the amendment, and explained the impact of eCTD v4.0 in Japan within pharmaceutical companies and the JPMA's efforts.
The program of this debriefing session and the presentation materials of the day are attached below as files for your direct viewing. Unauthorized copying or reproduction of the contents of the attached materials on this website is strictly prohibited.
Date, time and place
| Date and Time | Location |
|---|---|
| Wednesday, June 10, 2020, 13:00-15:30 | Webex
Access information will be provided to applicants on June 5. |
Information and Program
Program/Precautions for Opening (304KB)
Presentation materials for the day
| Presentation | Speaker |
|---|---|
|
Ryo Saito (Japan Pharmaceuticals and Medical Devices Agency, Review Management Division) |
|
|
Ryo Saito (Japan Pharmaceuticals and Medical Devices Agency, Review Management Division) |
|
| Natsuko Hamada (Japan Pharmaceutical Manufacturers Association, Pharmaceutical Affairs Committee) | |
| Kayoko Ichikawa (M8 Deputy Topic Leader, Japan Pharmaceutical Manufacturers Association) | |
The End