Electronic Data Submission in Japan

Project Scope

To raise awareness of eData submission to PMDA globally, especially focusing on PMDA specific requirements and practical challenges. To provide ideas for improvements for eData submission process/deliverables and to discuss better solution for both for PMDA and sponsor/CRO.

Objectives:

1. Produce a white paper to clearly describe PMDA specific requirements, best practice and suggestion for improvements

2. Create a presentation on tips of eData submission to PMDA to be presented at a Webinar, SDE or Connect

Project Leads	Email
Kazuki Fukuzawa	kazuki.fukuzawa@astrazeneca.com
Koichi Yamaguchi	yamaguchi_koichi@lilly.com
Takashi Kitahara	takashi.kitahara@novartis.com
Shinichi Hotta	shinichi.hotta@sumitomo-pharma.co.jp
Yasuhiro Iijima	yasuhiro.iijima@novartis.com
Yoshiko Kitagawa	yo.kitagawa@ono-pharma.com
Nicola Newton, PHUSE Project Coordinator	nicky@phuse.global

Published Deliverables	Date
Best Practices for the Submission of Data in Japan	09-June-2022
(E) Validation Error	03-May-2023