Japan is considering a new approach to its “special” market expansion re-pricing that would exclude drug sales tied to private…
REGULATORY
MHLW Outlines Envisaged Cases of Regulatory Submissions without Japanese Data, Covering Rare Disease Drugs
The Ministry of Health, Labor and Welfare (MHLW) issued a notification on October 23 spelling out cases in which drug makers can file regulatory applications for rare disease treatments without conducting clinical trials in Japanese patients. The notification sorted out…
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