When shopping for skincare at Japanese drugstores, do you often see the words "Medicated" (薬用) or "Quasi-drug" (医薬部外品) on the packaging? Yii will take you on a deep dive into this unique Japanese classification, teaching you how to identify truly "effective skincare" while shopping.
Does "Quasi-drug" mean more effective? A guide to skincare classification, ingredients, and common myths.
When shopping for skincare at Japanese drugstores, do you often see the words "Medicated" (薬用) or "Quasi-drug" (医薬部外品) on the packaging? Many people mistake them for actual medicine or assume they are simply "better" than regular skincare. In reality, "Quasi-drug" is a strictly regulated category under Japan’s Pharmaceutical and Medical Device Act (PMDA).
Yii will take you on a deep dive into this unique Japanese classification, teaching you how to identify truly "effective skincare" while shopping.
What is a "Quasi-drug"?
Under Japan’s PMDA (formerly known as the Pharmaceutical Affairs Law), skincare products are divided into three main categories. A "Quasi-drug" (Japanese: 医薬部外品) sits right between "Medicine" and "General Cosmetics."
The core definition is that it contains "Active Ingredients" approved by the Japanese Ministry of Health, Labour and Welfare (MHLW). These ingredients must be present in specific concentrations to provide targeted prevention or improvement effects, such as whitening, anti-inflammation, acne prevention, or body odor control.
Medicine vs. Quasi-drug vs. Cosmetics
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|
Japanese Name |
Definition |
|
Medicine |
医薬品 (Iyakuhin) |
Drugs containing ingredients approved by the MHLW for the purpose of "treatment." Includes prescription drugs and Over-The-Counter (OTC) drugs available at drugstores. |
|
Quasi-drug |
医薬部外品 (Iyakubugaihin) |
Not a medicine, but similarly approved by the MHLW. Contains specific active ingredients to ensure improvement or prevention of specific skin concerns. Gentle yet effective, suitable for long-term use. |
|
General Cosmetics |
化粧品 (Keshouhin) |
Products used only for beautifying appearance or cleansing. All ingredients must be listed; they do not possess specific medicinal effects. |
Why are Quasi-drugs more trustworthy?
While general cosmetics only need to list all ingredients, a "Quasi-drug" must clearly list its officially certified "Active Ingredients" on the packaging. Common examples include:
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Anti-inflammatory & Soothing:
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Dipotassium Glycyrrhizate: Often found in products for sensitive skin; effectively suppresses skin inflammation and redness.
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Whitening & Spot Fading:
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Tranexamic Acid: Inhibits melanin production and prevents dark spots.
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Vitamin C Derivatives: Enhances skin brightness and radiance.
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Acne Prevention:
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Salicylic Acid: Softens keratin and prevents clogged pores.
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Fun Fact: Legally, if a product packaging features the word "Medicated" (薬用 - Yakuyou), it is equivalent to a "Quasi-drug."
Behind the certification: A brand's commitment
Obtaining "Quasi-drug" certification is no easy feat; it is a time-consuming and high-cost marathon of quality.
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Timeline: Even if a product uses existing approved ingredients, the review cycle typically takes 6 to 8 months. If new ingredients or new efficacies are involved, the process can extend to 1 or 2 years. This period includes rigorous safety testing, stability experiments, and technical reviews by government agencies like the PMDA.
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Costs: Besides government administrative fees, brands must invest heavily in third-party testing, management by a Japanese Marketing Authorization Holder (MAH), and professional consultants for complex eCTD electronic filings. Costs start from 1.5 to 3 million JPY (approx. 80,000 to 150,000 HKD).
Companies willing to invest such significant time and capital represent a commitment that goes beyond chasing short-term market trends. It shows they are serious about product efficacy and providing the highest level of legal protection for consumer safety.
How to identify them on the packaging?
If the full ingredient list on the back of a Japanese product is too long, look specifically for "Active Ingredient" (有効成分) on the label:
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Ingredient Order: General cosmetics list ingredients in descending order of concentration. However, Quasi-drugs usually list the "Active Ingredients" separately at the very top.
Do I need to choose a Quasi-drug?
If you are looking for long-term skin stability and health—or if you deal with recurring allergies, acne, or specific whitening goals—choosing a "Quasi-drug" offers more security. Its efficacy is backed by official scientific data, ensuring that the ingredients are both safe and effective.
Yii's products, specifically developed for sensitive skin, feature various officially certified active ingredients to ensure the safest protection while repairing your skin.
Click here to view the Yii Skincare Series!