ICH Project ICH M8 eCTD v4.0 Amendment Notification Briefing
June 10, 2020
To establish common specifications for electronic submission formats, ICH M8 has continued to review new specifications for the eCTD.
Following the issuance of Notice No. 0219-1 dated February 19, Reiwa 2, titled “Amendments to ‘Regarding Marketing Authorization Applications Using the Electronic Common Technical Document (eCTD)’,” we held an explanatory session.
At this briefing, PMDA provided an explanation focusing on the key points of the amendment to aid in understanding the notice. We also explained the impact of eCTD v4.0 on pharmaceutical companies in Japan and outlined JPMA’s initiatives.
The program for this briefing session and the presentation materials from the event are attached below, so you can view them directly. Please note that unauthorized copying or reproduction of the attached materials posted on this website is prohibited.
Date, Time, and Venue
| Date and Time | Location |
|---|---|
| Wednesday, June 10, 2020, 1:00 PM – 3:30 PM | Webex
Access information was sent to registrants on June 5. |
Information and Program
Program / Important Notes for the Opening (304KB)
Presentation Materials for the Event
| Presentations | Speakers |
|---|---|
| Ryo Saito (NIH, Review Management Department) | |
| Ryo Saito (NIH, Review Management Department) | |
| 03_Initiatives for the Pilot Test | Natsuko Hamada (Regulatory Affairs Committee, Japan Pharmaceutical Manufacturers Association) |
| Kayoko Ichikawa (Japan Pharmaceutical Manufacturers Association, M8 Sub-Topic Leader) | |