The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW Presents Policy for Use of “Specified Clinical Research” Data in Regulatory Submissions
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on March 31, providing its basic policy and points to note for the use of results obtained from “specified clinical research” in regulatory submissions. Specified clinical research (tokutei rinsho…
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