The Ministry of Health, Labor and Welfare (MHLW) on December 12 presented a draft outline of the FY2026 drug pricing…
REGULATORY
MHLW No Longer Requires Japanese Comparability Data for Certain Biosimilars: Q&A Update
The Ministry of Health, Labor and Welfare (MHLW) on January 25 announced a revision to its Q&As for guidance on the quality, safety, and efficacy assurance of biosimilars. With the update, the regulator now no longer requires comparability data in…
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