Japan to Adopt CDISC Clinical Data Standards from October 2016

Tuesday, May 5, 2015

Source: Fierce Pharma Asia

Japan's Ministry of Health, Labor and Welfare (MHLW) will require drugmakers to use the Clinical Data Interchange Standards Consortium for submitting clinical trials starting in October 2016, according to a notice issued in Japanese. CDISC-based electronic submissions will become the main way to send in data covering efficacy, safety, administration, and dosage. The same format will apply for postmarketing clinical trials, but if electronic data were not submitted at the time of the original application for marketing approval, the CDISC format electronically is not required, the MHLW said.

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