Electronic Data Submission in Japan

This project aims to raise global awareness of PMDA eData submission requirements, focusing on practical challenges and opportunities for improvement. It supports the development of clearer, more efficient processes and solutions for both regulators and sponsors/CROs. 

Key objectives include delivering a white paper that highlights differences between FDA and PMDA electronic data submission requirements, providing a streamlined reference for adapting CRT packages across agencies. The project will also develop an AI-powered prompt library to support compliance checks against PMDA regulations, improving submission quality and efficiency through the use of Generative AI. 

In addition, the team will create and deliver a presentation with practical guidance and tips for PMDA eData submissions, to be shared through webinars or PHUSE events (e.g. SDEs or Connects), promoting best practices and broader industry understanding. 

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

Alex Pearce, PHUSE Project Coordinator

alexandra@phuse.global

 Best Practices for the Submission of Data in Japan

09-June-2022

(E) Validation Error

03-May-2023