Drug Evaluation Committee Japanese Translation of FDA's eCTD-related Notification January 2017
Electronic Information Subcommittee
January 2017
The Electronic Information Subcommittee of the Drug Evaluation Committee (Drug Evaluation Committee Electronic Information Subcommittee) of the Japan Pharmaceutical Manufacturers Association (JPMA) has been working to promote and disseminate information on eCTD to Japan.
It has already spread to the point where 140 eCTDs (fiscal year 2015) are submitted annually (more than 80% of team review items), and is on track to become mandatory in April 2020.
Meanwhile, the globalization of drug development and application for approval is accelerating, and the use of overseas eCTDs and the involvement of Japanese personnel in the preparation of eCTDs overseas are increasing. Against this backdrop, there is a growing need for Japanese eCTD and regulatory affairs staff to understand US and European eCTD.
In this issue, we have translated the "Guidelines for eCTD-based Approval Applications" and "PDF Specifications" from the US eCTD-related notifications into Japanese. We hope that all parties concerned will find it helpful.
We hope that you will also find it useful in conjunction with the Japanese translation of the EU eCTD Specification for eCTD Module 1, which was published in July 2016.
Japanese Translation of EU module1 eCTD Specification
Japanese Translation of FDA's eCTD-related Notification (January 2017) (660KB)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables