Regulatory

Japan quasi-drug (医薬部外品)

What is Japan quasi-drug?

Japan splits personal care into cosmetics and quasi-drugs. Anything making a whitening, anti-wrinkle, deodorant or medicated-acne claim falls into the quasi-drug tier, which needs pre-market approval from the MHLW and takes far longer than a cosmetic notification. Many Korean functional cosmetics land in this tier.

At a glance

Category
Regulatory
Also known as
医薬部外品 · 일본 의약부외품
Korean term
일본 의약부외품
Last reviewed
July 23, 2026

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