On 27 April, the Japanese Ministry of Health, Labour and Welfare issued the technical notification for electronic data submission and a technical conformance guide. The technical notification states that the MHLW will require drug makers to submit electronic data in CDISC standard format beginning 01 October 2016, with a 3.5 year transitional period.

 

To view the technical notification, questions and answers regarding the technical notification, and the technical conformance guide, please visit the links below (content in Japanese).

 

Technical Notification for Electronic Data Submissions
Questions & Answers for the Technical Notification 

Technical Conformance Guide in Japanese

Technical Conformance Guide in English