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FAQs on Electronic Study Data Submission (Excerpt)

1. 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”.
 
2. Reference

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 January 24, 2019)

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 “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 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 January 24, 2019)

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)


3. FAQs on Electronic Study Data Submissin (in Japanese)

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FAQs on Electronic Study Data Submission (Excerpt)
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