PMDA Data Submissions

New Drug Review with Electronic Data

Data Standards Catalog (2023-02-28)

FAQs on Electronic Study Data Submission (English version, April 3, 2023)

Study Data Validation Rules Version 4.0 (2023-02-28)

FAQs on Electronic Study Data Submission (English version, June 27, 2022)

Technical Conformance Guide (English version, April 1, 2022)

Study Data Validation Rules Version 1.0 (2015-11-18)

Study Data Validation Rules Version 2.0 (2019-09-27)

Study Data Validation Rules Version 3.0 (2021-12-15)

Explanation of Electronic Study Data (Form A)

Explanation of Electronic Study Data (Form B)

PMDA Workshops (in Japanese)

Electronic Data Submission and Utilization in Japan

Understanding PMDA Engines

Best Practices for the Submission of Data in Japan

Electronic Data Submission to PMDA: Our experiences and matters of concern

Lessons Learned for Successful e-Study Data Submission to the PMDA toward the End of Transitional Period

Challenges of Submitting Electronic Study Data to Two Authorities: the PMDA & FDA

Process optimization for efficient and smooth e-data submissions to both FDA and PMDA