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Japan to accept electronic study data for new drugs from FY 2016

This article was originally published in SRA

Executive Summary

Japan's medicines regulator will in fiscal year 2016 start to accept electronically-submitted study data from drug makers seeking market approval, as part of the agency's plan to make electronic submission for study data mandatory. The Ministry of Health, Labour and Welfare explained the new rule in a notification on electronic submission of study data for new drug applications 1,2.

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