Biosimilars
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Administrative Notice January 25, 2024 Guideline for Ensuring the Quality, Safety, and Efficacy of Biosimilars (PSEHD/PED) Notification No. 0204, Ministry of Health, Labour and Welfare (MHLW), dated February 4, 2020
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Provisional Translation (as of December 2024) PFSB/ELD Notification No. 0214-1 February 14, 2013
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