The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
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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