REGULATORY

Japan Eases Documentation Requirements for Excipients Listed in Foreign Pharmacopoeias

April 17, 2026
Japan’s Ministry of Health, Labor and Welfare (MHLW) has streamlined the approval application requirements for pharmaceutical excipients manufactured overseas in line with US and European pharmacopoeias. Under the revision, excipients produced based on the US Pharmacopeia-National Formulary (USP-NF) or the…

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