Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
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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