ICH Project ICH M8 eCTD v4.0 Revision Notification Briefing
June 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 the "Application for Approval by Electronic Common Technical Document (eCTD)"," Pharmaceutical and Pharmaceutical Affairs Bureau of Japan (PAPB) issued "0219 No. 1," dated February 19, 2020, 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 of the meeting
| Date and time | Place |
|---|---|
| Wednesday, June 10, 2020, 13:00-15:30 | Webex
Access information will be provided to applicants on June 5. |
Information, Program
Program / Opening Remarks (304KB)
Presentation materials for the day
| Presentations | Speakers |
|---|---|
| Ryo Saito (Department of Review Management, Pharmaceuticals and Medical Devices Agency) | |
| Ryo Saito (Drug and Medical Devices Agency, Review Management Department) | |
| Natsuko Hamada (Regulatory Affairs Committee, Japan Pharmaceutical Manufacturers Association) | |
| Kayoko Ichikawa, M8 Deputy Topic Leader, Japan Pharmaceutical Manufacturers Association | |