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New Drug Review with Electronic Data

In recent drug development, the use of data-based quantitative information such as those using modeling and simulation (M&S) methods has been proactively promoted in decision-making process.

Under such circumstances, PMDA recognizes the need for accumulating electronic study data, analyzing the data by advanced methods, and making use of the data in the process of its reviews and consultations. The use of such accumulated data is expected to reduce the workload of regulatory submission for sponsors, improve PMDA's evidence-based reviews and consultations, and lead to development of new guidelines, which will eventually result in the rise of the success rate of drug development.

This webpage provides related information about new drug review with electronic data.

Our vision for Advanced Review

Notifications

Notification on Handling of Submission of Electronic Study Data for New Drug Applications (PSEHB/PED Notification No. 0401-10, by the Director of Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, dated April 1, 2022)

Question and Answer Guide Regarding "Notification on Handling of Submission of Electronic Study Data for New Drug Applications” (Administrative Notice of the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, dated April 1, 2022)

New Drug Applications Using the Gateway System (PSEHB/PED Notification No. 0401-7, by the Director of the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, dated April 1, 2022)

Technical Conformance Guide on Electronic Study Data Submissions (PMDA/CPE Notification No. 0401003 and PMDA/CRS Notification No. 0401001, by the Director of Center for Product Evaluation and the Director of Center for Regulatory Science, Pharmaceuticals and Medical Devices Agency, dated April 1, 2022)
 

FAQs on Electronic Study Data Submission

This document summarizes inquiries on electronic study data submission received by the PMDA in a Q&A format.

Please utilize these Q&A to resolve problems and questions related to electronic study data submission.
 
Notice: This is an English version of the following FAQs on electronic study data submission published on June 27, 2022.

 

Explanation of Electronic Study Data (Form A and Form B)

 

Data Standards Catalog and Study Data Validation Rules

- Version 1.0 (2015-11-18) Acceptable from Oct 1, 2016 to Mar 31, 2021 (application date)
- Version 2.0 (2019-09-27) Acceptable from Apr 1, 2020 to Mar 31, 2023 (application date)
- Version 3.0 (2021-12-15) Acceptable from Jan 1, 2022 (application date)

  • CDISC Data Validation Software

The software that PMDA is using is Pinnacle 21 Enterprise 4.0.2, and the engine corresponding to the validation rules are as follows.
- PMDA 1511.6 (Validation Rule Version 1.0)
- PMDA 1810.3 (Validation Rule Version 2.0)
- PMDA 2010.2 (Validation Rule Version 3.0)

 

Reference

Information related to the pilot projects that were conducted before the initiation of data submission/accumulation is here.

JCN 3010005007409

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New Drug Review with Electronic Data
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