Drug Evaluation Committee Japanese Translation of FDA's eCTD-related Notification January 2017
Electronic Standard for Medical Information Expert Committee
January 2017
The Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Electronic Standard for Medical Information Expert Committee(Drug Evaluation Committee Electronic Standard for Medical Information Expert Committee) has been working to promote and disseminate information about eCTD to Japan.
Already, 140 eCTDs (fiscal year 2015) are submitted annually (more than 80% of team-reviewed items), and the system 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 creation 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 useful.
We hope you will also find the Japanese translation of the EU eCTD Specification for eCTD module1 published in July 2016.
Japanese Translation of EU module1 eCTD Specification
Japanese Translation of FDA's eCTD-related Notification (January 2017) (660KB)