Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
Pharmaceutical Affairs Council Approves Basic Plan for “Humanitarian Trials”
The Ministry of Health, Labor and Welfare (MHLW) has compiled a basic plan for the implementation of “humanitarian trials,” a Japanese version of the compassionate use system. The plan would permit expanded access to new drugs following domestic “main studies,”…
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