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Based on the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (short for "Pharmaceutical and Medical Devices Law"), medicated cosmetics are regarded as quasi-drug. Besides, the Minister of Health, Labor and Welfare (MHLW) approval is required for each quasi-drug in the manufacture and sale.
On March 29, 2018, MHLW released the instructions for applying marketing approval for medicated soaps, which specified the types, standards, combination concentration, usage and dosage of the medicinal soap's active ingredients.
It is noteworthy that, after the instructions come into effect, the “8. Medicated soap (include facial cleanser)” in the list of the permitted active ingredient in medicated cosmetics will be invalidated. For specific specifications, please refer to these instructions.
