The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
Japan to Allow Submissions without Japanese Data If All Requirements Met
Members of a health ministry panel on pharmaceutical regulations on February 8 broadly agreed on a proposal to allow regulatory filings without clinical study data in Japanese patients if all requirements are met, such as the completion of pivotal trials…
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