Drug Evaluation Committee Japanese Translation of EU module1 eCTD Specification July 12, 2016
Electronic Information Subcommittee
July 2016
The Electronic Information Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JMPMA) (Drug Evaluation Committee Electronic Information Subcommittee) has been working to promote and disseminate information on eCTD to Japan.
It has already spread to the point where 140 eCTDs (in FY2015) 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 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)
Deliverables of the Drug Evaluation Committee Return to list of all deliverables