On January 23, 2026, Japan notified the World Trade Organization (WTO) of a proposed partial amendment to the Standards for Biological Raw Materials under notification G/TBT/N/JPN/898. Issued by the Ministry of Health, Labour and Welfare (MHLW), the Standards set out requirements for the use of biological raw materials in the manufacture of drugs, quasi-drugs, cosmetics, medical devices, and regenerative medical products.
Original regulatory document
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