Japan’s cost-effectiveness assessment (CEA) panel has approved a revised handling policy for the CEA system for FY2026, with the health…
REGULATORY
MHLW to Require CTD-Based Submissions for Generics, Effective March 2017
The Ministry of Health, Labor and Welfare (MHLW) will require regulatory filing for generic drugs in the Common Technical Document (CTD) format as a basic rule, beginning on March 1, 2017.The new requirement will exclude biologics, radiopharmaceuticals, recombinant products, cell…
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REGULATORY
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