What Are Quasi-Drugs? Decoding Japan’s Skincare Myths – Yii

What Are Quasi-Drugs? Decoding Japan’s Skincare Myths

       

什麼是醫藥部外品? 一文破解日本護膚品選購迷思

Introduction

When visiting a cosmetics store or pharmacy, the array of products can be overwhelming. While comparing items on the shelves, you may notice a category labeled Quasi-drug (医薬部外品). Many people are unclear about its distinctions, so this article explores the features of Quasi-drugs and how Yii leverages specialized ingredients and certified quality to lead the skincare trend!

Quasi-Drug Basics: The Pharmaceutical Affairs Law

The Pharmaceutical Affairs Law (formerly the Drug Law) aims to ensure the safety and efficacy of pharmaceuticals and medical devices, preventing risks to public health. While medicines can aid recovery, unsafe or ineffective drugs may pose life-threatening dangers. Thus, the Japanese government established regulations to govern pharmaceuticals and advertisements, safeguarding national health and safety.

Five product categories regulated by the law:

Pharmaceuticals

Prescription drugs, over-the-counter medications, vaccines, etc.

Quasi-drugs

Skincare products, vitamin preparations, depilatories, hair dyes, antiperspirants, medicated soaps and toothpastes, etc.

Cosmetics

Skincare, toners, foundations, shampoos, lip balms, perfumes, body washes, hair care products, etc.

Medical Devices

Pacemakers, artificial joints, thermometers, surgical tools, etc.

Regenerative Medicine Products

Cell-based products (e.g., iPS cells), gene therapy products, etc.


What Are Quasi-Drugs?

Under Japan’s Pharmaceutical Affairs Law, Quasi-drugs are a strictly regulated category, requiring rigorous review by the Ministry of Health, Labour and Welfare (MHLW) to ensure safety and specific efficacy (e.g., whitening, anti-inflammatory, or skin barrier repair). Approved products receive an MHLW certification. Beyond skincare, Quasi-drugs include vitamin preparations, depilatories, hair dyes, antiperspirants, medicated soaps, and toothpastes. Certified Quasi-drugs have verified ingredients and efficacy, ensuring consumer safety and confidence.

Per the Pharmaceutical Affairs Law, Quasi-drugs:

  1. Prevent nausea, bad breath, or body odor.
  2. Prevent heat rash, dermatitis, etc.
  3. Prevent hair loss, promote hair growth, or aid hair removal.
  4. Control pests like rats, flies, mosquitoes, or fleas for human or animal health.
  5. Have mild effects on the body.
  6. Are not mechanical devices.

Positioning of Quasi-Drugs

Unlike cosmetics, which offer surface-level care, Quasi-drug skincare products contain high-potency active ingredients to effectively improve or prevent specific issues. Unlike pharmaceuticals, they lack medicinal components, ensuring no drug resistance with long-term use, providing stable and safe repair. 

Certified by the MHLW, Quasi-drugs feature pure, low-irritation ingredients, ideal for sensitive skin, enhancing consumer trust. For those seeking high-quality skincare, Japan Quasi-drugs represent a blend of science and safety, embodying Yii’s skincare standards.

  • Quasi-drugs: Positioned between cosmetics and pharmaceuticals, MHLW-certified, with effective ingredients to address specific issues, no drug resistance with long-term use, ideal for sensitive and mature skin.
  • Pharmaceuticals: Contain medicinal components for disease treatment, provide immediate pharmacological effects, may cause side effects or drug resistance, require medical supervision.
  • Cosmetics: Offer care benefits but lack MHLW certification, with limited efficacy, suitable for basic needs.

Yii’s Quasi-drug products are ideal for compromised and sensitive skin, delivering noticeable improvements in 7-14 days*, addressing surface issues while repairing skin health at its core.

醫藥部外品 意思

Quasi-Drug Features: A Case Study on Sensitive Skin

For those with sensitive skin, redness, dryness, and barrier damage are common challenges. Yii’s Quasi-drug products, certified by the MHLW, feature high-potency active ingredients. For instance, Gel L harnesses houttuynia cordata for anti-inflammatory and soothing effects, calming redness and forming a protective skin barrier, ideal for compromised and sensitive skin, with no risk of drug resistance over long-term use, improving skin health at its core. In contrast, steroids rapidly suppress eczema inflammation but may cause skin thinning, pigmentation, or drug resistance with prolonged use. For specific conditions, consult a doctor for professional advice to choose the best care.


 

Feature

Quasi-drug

Gentle repair, no drug resistance, long-term safe use, MHLW-certified, safe and low irritation

Slower results, at least 7-14 days to see effects

Steroids

Rapid inflammation suppression, immediate effects

Long-term use may cause skin thinning, drug resistance, requires medical supervision


Quasi-drugs provide safe, stable sensitive skin repair and compromised barrier care, offering a side-effect-free skincare solution.

Quasi-Drug Spotlight: Yii Gel L

Yii’s Gel L, a certified Quasi-drug, is crafted under Japan’s stringent quality control, ensuring pure and safe ingredients. Featuring porcine placental extract as its core, combined with houttuynia cordata, fennel, clove flower, and Japanese ligusticum, it offers a lightweight, non-sticky gel texture, forming a protective barrier to instantly hydrate and calm redness, locking in moisture and repairing damaged barriers. Ideal for sensitive skin, it delivers visible improvements in at least 7-14 days*. Certified by the MHLW as a Quasi-drug and passing U.S. FDA allergy testing, it ensures premium quality. 

Gel L smooths fine lines and dryness, soothes redness, brightens complexion, and firms contours, restoring a healthy glow. Discover Yii’s Skin Nourishment Products for transformative skincare!

Conclusion

Quasi-drugs, rigorously regulated by Japan’s Pharmaceutical Affairs Law and MHLW certification, deliver reliable results without drug resistance, ideal for those seeking high-quality skincare. Discover Yii’s Quasi-drugs to experience Japan-made, premium skincare and awaken your skin’s radiant health!

*Data based on actual feedback from 20 respondents in 2025. Individual results may vary.