Japan’s Ministry of Health, Labor and Welfare (MHLW) on March 5 unveiled the revised NHI prices for drugs subject to…
REGULATORY
Submission of CDISC-Based Clinical Data Required from October 2016: Notification
The Ministry of Health, Labor and Welfare issued a notification on April 27, which specified that the ministry will require drug makers to submit electronic clinical trial data based on CDISC standards, beginning with products filed for marketing approval on…
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REGULATORY
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