Drug Evaluation Committee Japanese Translation of EU module1 eCTD Specification July 12, 2016
Electronic Standard for Medical Information Expert Committee
July 2016
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 spread the word about eCTD in Japan.
Already, 140 eCTDs (fiscal year 2015) are submitted annually (more than 80% of team-reviewed items), and the mandatory use of eCTDs is on the horizon for April 2020.
Meanwhile, the globalization of drug development and application for approval is accelerating, and the use of overseas eCTD and the involvement of Japanese personnel in the creation of overseas eCTD are increasing. Against this background, there is a growing need for Japanese eCTD staff and pharmaceutical affairs staff to understand European and US eCTD.
We have prepared a Japanese translation of the EU eCTD Specification for Module 1, which differs from the Japanese eCTD Specification, and hope that it will be of interest to all concerned.
Japanese Translation of EU module1 eCTD Specification (1.4MB)