Japan's market for health, beauty, and personal care products is characterized by a unique regulatory category known as "quasi-drugs" (医薬部外品 - iyaku bugaihin). Positioned distinctively between pharmaceuticals (医薬品 - iyakuhin) and cosmetics (化粧品 - keshōhin), quasi-drugs offer a pathway for products that provide specific, albeit mild, physiological effects or preventive benefits that go beyond the general grooming functions of cosmetics, yet do not meet the criteria for full pharmaceutical classification. For international companies looking to introduce products with functional claims into Japan, understanding the definition, scope, regulatory requirements, and marketing possibilities for quasi-drugs is crucial.

Defining "Quasi-Drugs" under Japan's PMD Act

The Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act or Yakkiho) provides the legal definition for quasi-drugs. Article 2, Paragraph 2 of the PMD Act defines quasi-drugs as articles (excluding medical devices and regenerative medicine products) that have a mild action on the human body and are designated by the Minister of Health, Labour and Welfare (MHLW) for specific purposes. These purposes include:

1. Preventing nausea and other discomforts: Such as certain mild motion sickness remedies.
2. Preventing heat rash, soreness, etc.: Examples include medicated powders or creams for mild skin irritations like diaper rash.
3. Promoting hair growth, or removing hair, or having other effects on hair: This covers certain types of hair restorers, depilatories, and some hair dyes or perming agents with specific active ingredients.
4. Exterminating or preventing mice, flies, mosquitoes, fleas, and other similar pests detrimental to human or animal health or sanitation: This includes certain insecticides and repellents intended for application to the human body or for sanitary purposes directly related to human health (e.g., in living spaces, but not agricultural pesticides).
5. Other designated purposes: The MHLW can designate additional purposes for quasi-drugs. This provision is particularly important as it encompasses a wide range of products, most notably "medicated cosmetics," which aim to achieve specific effects beyond basic cosmetic functions.

The defining characteristic of quasi-drugs is their intermediate position. They are permitted to claim certain "effects/efficacy" (効能効果 - kōnō kōka) that cosmetics cannot, due to the inclusion of recognized active ingredients. However, their action on the body is considered mild, and the scope of their permissible claims is significantly more limited than that of pharmaceuticals, which are intended for the diagnosis, treatment, or prevention of diseases.

Key Categories and Examples of Quasi-Drugs

The quasi-drug category is diverse, encompassing a variety of product types:

• Medicated Cosmetics (薬用化粧品 - Yakuyō Keshōhin): This is arguably the largest and most commercially significant segment. These products are used like cosmetics but contain active ingredients recognized for specific quasi-drug effects. Common examples include:
  • Skin whitening/brightening products (containing ingredients like vitamin C derivatives, tranexamic acid, or arbutin that aim to suppress melanin production).
  • Anti-aging products (claiming to prevent wrinkles or improve skin elasticity through specific active ingredients like retinol derivatives or niacinamide, within quasi-drug limits).
  • Anti-acne products (containing ingredients like salicylic acid or isopropyl methylphenol).
  • Medicated soaps and body washes (claiming to prevent body odor or skin irritation).
  • Medicated toothpastes and mouthwashes (claiming effects such as prevention of gingivitis, periodontitis, bad breath, or tooth whitening via recognized actives).
  • Medicated shampoos and conditioners (e.g., anti-dandruff formulations, or those claiming to prevent hair loss and promote healthier hair).
• Preventive Products: Items for preventing body odor (deodorants with active ingredients), bad breath, heat rash, chapped skin, or frostbite.
• Hair Care Products (beyond medicated cosmetics): This can include certain hair dyes, permanent wave solutions, and milder hair growth tonics or stimulants that fall under quasi-drug regulations due to their active ingredients and claimed effects.
• Oral Care Products: Beyond medicated toothpastes, this may include specific mouthwashes with antibacterial or anti-inflammatory claims recognized for quasi-drugs.
• Bath Additives: Products for the bath containing active ingredients (e.g., minerals, herbal extracts) that claim effects such as relieving fatigue, soothing muscle aches, improving circulation, or alleviating dry skin.
• Sanitary Products and Pest Control: Contact lens care solutions (disinfecting solutions), certain types of sanitary napkins or tampons making specific functional claims (e.g., odor control via active ingredients), and insect repellents for direct human application.

The Regulatory Framework for Quasi-Drugs

Bringing a quasi-drug to the Japanese market involves navigating a specific regulatory pathway that differs from both pharmaceuticals and cosmetics.

Licensing Requirements:

• Marketing Authorization Holder (MAH) License for Quasi-Drugs: A company intending to place quasi-drugs on the Japanese market must obtain an MAH license specifically for quasi-drugs (医薬部外品製造販売業許可 - iyaku bugaihin seizō hanbai-gyō no kyoka) from the MHLW or the prefectural governor, depending on the product's nature and manufacturing location. The MAH is responsible for the product's quality, safety, and regulatory compliance in Japan.
• Manufacturing License for Quasi-Drugs: Manufacturing quasi-drugs within Japan requires a site-specific manufacturing license for quasi-drugs (医薬部外品製造業許可 - iyaku bugaihin seizō-gyō no kyoka). Foreign manufacturing sites must be accredited by the MHLW (外国製造業者認定 - gaikoku seizōgyōsha nintei).

Product Authorization: Approval vs. Notification

The authorization pathway for an individual quasi-drug product depends on its composition and claimed effects:

1. Marketing Approval (承認 - Shōnin): Full marketing approval from the MHLW is generally required for quasi-drugs that:
   • Contain new active ingredients not previously approved in Japan for quasi-drug use.
   • Involve new dosages or administration routes for existing active ingredients.
   • Claim new "effects/efficacy" not covered by established standards.
     The application dossier for approval must include data on the product's quality, safety (e.g., irritation studies, sensitization studies, sometimes systemic toxicity depending on the ingredient and exposure), and data supporting the claimed quasi-drug effects/efficacy. While less extensive than for pharmaceuticals, this process can still be time-consuming and require significant data generation.
2. Notification (届出 - Todokede) / Adherence to Standards: For many common quasi-drugs, a simpler pathway may exist if the product conforms to established MHLW standards. These standards are often laid out in official compendia such as the "Comprehensive Licensing Standards of Quasi-drugs by Category" (医薬部外品種類別許可基準 - iyaku bugaihin shuruibetsu kyoka kijun) or other MHLW notifications. If a product's active ingredients, their concentrations, formulation, and claimed effects/efficacy fall entirely within these pre-approved standards, the MAH might only need to notify the prefectural government or follow a streamlined process, rather than undergoing a full MHLW approval. This is common for many "medicated cosmetics" and other well-established quasi-drug types.

Quality Management Standards:

• GQP (Good Quality Practice): MAHs for quasi-drugs must comply with GQP standards (医薬部外品GQP省令). These ensure proper quality control of products released to the market, handling of quality-related issues, and supplier management.
• GMP (Good Manufacturing Practice): Manufacturing sites (both domestic and accredited foreign sites) must comply with GMP standards applicable to quasi-drugs (医薬部外品GMP). While sharing principles with pharmaceutical GMP, the specific requirements may be adapted to the risk profile of quasi-drugs.

Labeling Requirements for Quasi-Drugs

Labeling is a critical aspect of compliance and consumer information. Key labeling requirements for quasi-drugs include:

• Product Category Identification: The product must be clearly identified as a "Quasi-Drug" (「医薬部外品」) on the immediate container or wrapper, and on the outer packaging.
• MAH Information: Name and address of the Marketing Authorization Holder.
• Product Identification: Product name, manufacturing number or code (lot number), and net weight or volume.
• Full Ingredient Listing (全成分表示 - Zen-seibun Hyōji): All ingredients must be listed on the container or package, generally in descending order of predominance, similar to the requirement for cosmetics. This allows consumers to identify potential allergens or substances they wish to avoid.
• Approved Effects/Efficacy (効能効果 - Kōnō Kōka): The specific "effects/efficacy" claims that have been approved or are recognized for that quasi-drug formulation can, and generally must, be stated. This is a primary differentiator from cosmetics.
• Directions for Use and Precautions: Clear instructions for proper usage and any necessary warnings or precautions related to storage or handling.
• Country of Origin: If the product is imported.
• Contact Information: For consumer inquiries.

Advertising Regulations for Quasi-Drugs

Advertising for quasi-drugs is regulated under the PMD Act (primarily Articles 66-68, which prohibit false, exaggerated, or misleading advertising, and advertising of unapproved effects) and specific MHLW guidelines, such as the "Standards for Appropriate Advertising of Pharmaceuticals, etc." (医薬品等適正広告基準).

• Permitted Claims: The most significant aspect of quasi-drug advertising is the ability to promote the approved or recognized "effects/efficacy." For example, a medicated toothpaste (quasi-drug) can advertise its effect of "preventing gingivitis," while a standard cosmetic toothpaste cannot.
• Prohibited Claims:
  • Claims must not suggest pharmaceutical-level therapeutic efficacy, such as "curing" a disease or treating a medical condition. The language must be carefully chosen to reflect the milder action and preventive or ameliorative nature of quasi-drugs.
  • The advertised claims must strictly be within the scope of the effects/efficacy recognized or approved for that specific quasi-drug formulation. Making claims beyond this scope is a violation.
  • Advertising must not be misleading, guarantee effects, or use expressions that could cause undue anxiety or hope.
  • Superlative claims (e.g., "the best," "No. 1") are generally restricted unless backed by objective, verifiable data and appropriately qualified.
• Comparison with Cosmetic Advertising: Quasi-drugs have significantly more latitude in making functional claims compared to cosmetics. Cosmetics are restricted to claims related to cleansing, beautifying, adding attractiveness, altering appearance, or maintaining the skin or hair in good condition. They cannot claim to affect the structure or physiological functions of the body in a way that quasi-drugs with active ingredients can.

Distinguishing Quasi-Drugs from Pharmaceuticals and Cosmetics

Understanding the boundaries between these three categories is essential:

Practical Implications for Businesses

The quasi-drug category offers a strategic option for companies looking to market products with functional benefits that fall between the strict therapeutic claims of pharmaceuticals and the general appearance-related claims of cosmetics.

• Strategic Product Classification: Correctly positioning a product—as a cosmetic, quasi-drug, or potentially a pharmaceutical—is a foundational strategic decision. It hinges on the ingredients, their concentrations, the intended use, and the desired marketing claims. Misclassification can lead to regulatory action.
• Formulation and Substantiation: Developing a quasi-drug often involves using active ingredients recognized by the MHLW at specified concentrations to align with established efficacy claims. If new active ingredients or novel claims are pursued, substantiation through safety and efficacy data will be necessary for MHLW approval.
• Marketing Advantages and Limitations: The ability to make specific "effect/efficacy" claims is the primary advantage of quasi-drug status over cosmetics. This allows for more direct and persuasive marketing messages. However, these claims must be meticulously aligned with the approved scope for the product.
• Regulatory Pathway and Time-to-Market: While potentially simpler than for new pharmaceuticals, the regulatory pathway for quasi-drugs (especially those requiring full MHLW approval) can be more complex and time-consuming than for standard cosmetics. Understanding the "Comprehensive Licensing Standards of Quasi-drugs by Category" can significantly streamline the process for products fitting established types.

Conclusion

Quasi-drugs occupy a distinctive and commercially important niche within Japan's regulatory system for consumer health and beauty products. They provide a valuable avenue for products offering specific, mild physiological or preventive benefits, supported by recognized active ingredients. For businesses, successfully navigating this category requires a clear understanding of its unique definition, the scope of permissible claims, the nuances of the approval or notification processes, and the specific requirements for labeling and advertising. While the regulatory hurdles may be more involved than for cosmetics, the ability to make substantiated functional claims can provide a significant competitive advantage in the discerning Japanese market.