On March 25, 2021, Japan Ministry of Health, Labour and Welfare (MHLW) issued and implemented four documents, which revised the ingredient standards and adjusted the corresponding pre-market application requirements of quasi-drug products.
To facilitate enterprises' applications for the manufacture and sale of quasi-drugs, MHLW also released a FAQs collection, which includes 29 questions relating to the marketing/manufacturing approval of quasi-drugs/cosmetics, formula and test methods, etc.
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Original regulatory document
