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On March 21, 2025, Japan Ministry of Health, Labour and Welfare (MHLW) issued notification announcing significant amendments to the Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021). JSQI 2021 is the foundational technical standard for quasi-drug ingredients, outlining the basic specifications and testing methods required for regulatory compliance.
This revision introduces several updates to both general testing methods and ingredient specifications, aiming to enhance quality control and regulatory consistency. The changes came into effect immediately upon publication, but a transition period will be in place until September 30, 2026, allowing companies to continue applying the previous standards during this time.
Along with the revisions to JSQI 2021, the MHLW has also updated the regulatory requirements for quasi-drug manufacturing and sales license applications.
