Electronic Data Submission in Japan

Unknown Attachment

Project Scope

Project Scope

To raise awareness of eData submission to the PMDA globally, focusing on PMDA requirements and practical challenges. To provide ideas for improvements for the eData submission process/deliverables and to discuss better solutions for both the PMDA and sponsors/CROs.

Objectives:

Produce a white paper that clarifies the key differences in electronic data submission requirements between the FDA and the PMDA, providing an updated and streamlined reference to help practitioners efficiently determine what needs to be adjusted when repurposing a CRT package submitted to one authority for submission to the other.

Develop an AI-powered Prompt Library to verify compliance with PMDA regulations using Generative AI. Aligning the prompt library with the PMDA’s eData requirements improves submission accuracy and accelerates approval processes.

Create a presentation on tips for eData submission to the PMDA, to be presented at a webinar, SDE or Connect.

Project Leads	Email

Project Leads	Email
Rie Kageyama	rie.kageyama@mebix.co.jp
Shinichi Hotta	shinichi.hotta.jj@kyowakirin.com
Tomohiko Funai	funai_tomohiko@lilly.com
Yoshiko Kitagawa	yo.kitagawa@ono-pharma.com
Nicola Newton, PHUSE Project Coordinator	nicky@phuse.global

Click above for the latest project status.

Published Deliverables	Date

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