Ministry of Health, Labour and Welfare (MHLW)

The Ministry of Health, Labour and Welfare (MHLW) is the Japanese government ministry responsible for healthcare, labour, and welfare policy. Through its Pharmaceutical and Food Safety Bureau, MHLW regulates cosmetics and quasi-drugs under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (commonly called the PMD Act or Pharmaceutical Affairs Law).

Japan uses a dual classification system: "cosmetics" (keshouhin) are products with mild effects on the body, while "quasi-drugs" (iyaku bugaihin) are products with moderate pharmacological effects — including sunscreens, hair growth products, antiperspirants, and medicated cosmetics. Quasi-drugs require MHLW approval before marketing.

For cosmetics, Japan maintains a positive list of approved ingredients (Comprehensive Licensing Standards). Any ingredient not on the positive list requires a specific ingredient approval application. For quasi-drugs, each product must receive manufacturing and marketing approval from MHLW.

Imported cosmetics require a Marketing Authorization Holder (MAH) licensed in Japan who takes responsibility for the product's quality and safety. Japanese labeling requirements include full ingredient listing, product name, MAH name and address, and country of origin.