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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 our new approach.

Our vision for Advanced Review


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

Notifications

Revision of Basic Principles on Electronic Submission of Study Data for New Drug Applications (PFSB/ELD Notification No. 0124-1, by the Director of the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, dated March 18, 2020)

Question and Answer Guide Regarding “Basic Principles on Electronic Submission of 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 March 18, 2020)

Revision of Notification on Practical Operations of Electronic Study Data Submissions (PFSB/ELD Notification No. 0124-4, by the Director of the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, dated January 24, 2019)

Question and Answer Guide Regarding “Notification on Practical Operations of Electronic Study Data Submissions” (Administrative Notice of the Pharmaceutical Evaluation Division, Pharmaceutical Safety and Environmental Health Bureau, Ministry of Health, Labour and Welfare, dated March 18, 2020)

Revision of Technical Conformance Guide on Electronic Study Data Submissions (Notification No. 0124001, by the Director of the Office of Advanced Evaluation with Electronic Data, Pharmaceuticals and Medical Devices Agency, dated January 24, 2019)
 

FAQs on Electronic Study Data Submission (Excerpt)

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 April 10, 2019: some questions from “1. Questions on new drug review and consultation”; a question from “2. Questions on the relationship between electronic submission data and eCTD”; some questions from “3. Questions on electronic submission gateway”; all questions from “4. Questions on CDISC-conformant electronic study data”; and all questions from “5. Questions on electronic study data on clinical pharmacology”.


Attachment 8 and 8-2 mentioned in the FAQs are below.


The full document of FAQs is below.

 

Data Standards Catalog and CDISC Data Validation

- 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 (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.
- 1511.6 (Validation Rule Version 1.0)
- 1810.3 (Validation Rule Version 2.0)
 



 For any inquiries on this page, please send your message to this address: jisedaiPT●pmda.go.jp
 (Note: For the purpose of security, @ in the e-mail addresses are replaced with ●. Please replace ● with @ when you send an e-mail.)
 (Please note that not all inquiries would be answered respectively. Thank you for your understanding.)

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New Drug Review with Electronic Data
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