Japan's Over-The-Counter (OTC) pharmaceutical market is a significant sector, reflecting a public interest in self-medication for common ailments. The regulatory framework governing these products, primarily established under the "Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices" (PMD Act or Yakkiho), is characterized by a detailed risk-based classification system. This system categorizes OTC drugs into several distinct tiers, each with specific rules regarding sales, the involvement of healthcare professionals, information provision to consumers, and channels of distribution, including online sales. For businesses aiming to participate in or currently operating within this market, a thorough understanding of these categories—from the highly restricted "Guidance-Requiring Pharmaceuticals" to the more accessible Class 3 drugs—is indispensable for compliance and strategic planning.

The Foundation: OTC Pharmaceuticals in Japan

In Japan, OTC pharmaceuticals are termed "General-Use Pharmaceuticals" (一般用医薬品 - ippan-yō iyakuhin). They are defined as pharmaceuticals, excluding "Guidance-Requiring Pharmaceuticals," intended for use by consumers for self-treatment of minor illnesses and symptoms, based on their own selection and responsibility, often with information provided by pharmacists or registered sellers. This distinguishes them from "Medical-Use Pharmaceuticals" (医療用医薬品 - iryō-yō iyakuhin), which are supplied based on a prescription or under the direct guidance of a healthcare professional.

The rationale behind the multi-tiered classification of OTC drugs is to balance the promotion of appropriate self-medication with the imperative of consumer safety. The system is risk-based, meaning the level of restriction and professional intervention required for sale corresponds to the potential risks associated with the drug's ingredients, indications, or potential for adverse effects.

"Guidance-Requiring Pharmaceuticals" (要指導医薬品 - Yōshidō Iyakuhin): The Most Stringent OTC Class

Introduced with the 2014 revision of the PMD Act, "Guidance-Requiring Pharmaceuticals" represent the most tightly controlled category of non-prescription drugs.

Legal Basis and Definition:
As defined in Article 4, Paragraph 5, Item 3 of the PMD Act, these are pharmaceuticals (excluding those whose effects on the human body are not considered marked) that are intended to be used by consumers based on their selection with information from a pharmacist or other medical professional, and for which face-to-face provision of information and guidance by a pharmacist based on pharmaceutical knowledge is deemed necessary for their proper use.

Types of Drugs Designated:
This category typically includes:

1. Switch-OTC Drugs (スイッチOTC): Pharmaceuticals recently switched from prescription (medical-use) status to OTC status. These drugs are generally placed in this category for a specific period (typically around 3 years post-switch) to allow for careful monitoring of their use in a self-medication environment.
2. Direct-OTC Drugs (ダイレクトOTC): Pharmaceuticals approved directly as OTC drugs without prior marketing authorization as a prescription drug in Japan. These also remain in this category for a set re-examination period (often around 8 years) to gather sufficient safety and efficacy data in the OTC setting.
3. Certain Potent Drugs (劇薬 - gekiyaku): Specific drugs designated as "potent drugs" due to their pharmacological activity may also be classified as Guidance-Requiring Pharmaceuticals if deemed appropriate for OTC sale under strict pharmacist supervision.

Sales Regulations for Guidance-Requiring Pharmaceuticals:
The sale of these drugs is subject to the strictest conditions among all OTC categories:

• Face-to-Face Sales Only: Crucially, "Specific Sales" (特定販売 - tokutei hanbai), which include internet sales, mail-order, or any other non-face-to-face methods, are prohibited for Guidance-Requiring Pharmaceuticals (PMD Act, Article 36-5). They must be sold in a physical pharmacy setting where direct interaction can occur.
• Pharmacist-Only Sales: Only a licensed pharmacist (yakuzaishi) is permitted to sell or supply Guidance-Requiring Pharmaceuticals. Registered sellers cannot handle these products.
• Mandatory Information Provision and Guidance: The pharmacist is legally obligated to provide comprehensive information and guidance to the purchaser face-to-face, utilizing their pharmaceutical expertise. This includes explaining the drug's effects, side effects, interactions, and proper usage (PMD Act, Article 36-6). This goes beyond simple information provision and involves active guidance.
• Confirmation of User Information: Before selling, the pharmacist must confirm details about the intended user, such as age, gender, symptoms, concurrent medications, allergies, and medical history, to ensure the drug is appropriate.
• Quantity Limitations: The quantity sold is generally restricted to the minimum necessary for one person's use, typically one original package (e.g., one box or bottle).
• Prohibition of Sale to Non-Users (General Rule): As a general rule, these pharmaceuticals should not be sold to individuals who are not the intended users, unless there are legitimate reasons (e.g., a caregiver purchasing for an incapacitated patient, which would still require careful pharmacist assessment).
• Record-Keeping: Pharmacies must maintain detailed written records of each sale of a Guidance-Requiring Pharmaceutical for a period of two years. These records typically include the product name, quantity, date of sale, and information confirming that appropriate guidance was provided (PMD Act, Article 36-6, Paragraph 4, applying mutatis mutandis Article 14, Paragraphs 3 and 4).

"General OTC Pharmaceuticals" (一般用医薬品 - Ippan-yō Iyakuhin): The Three-Tier Risk-Based System

General OTC Pharmaceuticals, as defined in Article 4, Paragraph 5, Item 4 of the PMD Act, are further categorized into three classes based on their relative risk profiles. This classification determines the sales regulations, including who can sell them and the level of information provision required.

Class 1 Pharmaceuticals (第一類医薬品 - Dai-ichirui Iyakuhin)

These are OTC drugs considered to have the highest risk among the general OTC categories. Their side effects, if they occur, could potentially interfere with daily life, and thus they require particularly careful handling and professional advice.

• Examples: Some H2-receptor antagonists (for stomach acid), certain topical minoxidil preparations (for hair growth), and some emergency contraceptives (which have specific consultation and dispensing protocols).
• Sales Regulations:
  • Pharmacist-Only Sales: Class 1 Pharmaceuticals must be sold by a pharmacist (PMD Act, Article 36-9, Item 1). Registered sellers are not permitted to sell these drugs independently.
  • Mandatory Information Provision (Written and Oral): The pharmacist is obligated to provide the purchaser with detailed information about the drug, both orally and by using a written document (e.g., a standardized information sheet) (PMD Act, Article 36-10, Paragraph 1). This ensures the consumer receives and can retain key information.
  • Restrictions on Display: These drugs must be stored in a location within the pharmacy that is not directly accessible to consumers before consultation (e.g., behind the counter or in a locked display case). This is to ensure that a pharmacist is involved before a consumer selects the product.
  • Record-Keeping: While not as explicitly mandated for all sales as for Guidance-Requiring drugs, pharmacies are encouraged or may be required by administrative guidance to maintain records of Class 1 sales, particularly for products with higher monitoring needs.
  • "Specific Sales" (Internet Sales): Permitted, but with stringent requirements. A pharmacist must be available to provide information and respond to consultations online or by phone before the sale is finalized. The system must ensure the consumer has understood the information provided.

Class 2 Pharmaceuticals (第二類医薬品 - Dai-nirui Iyakuhin)

This category includes OTC drugs with a moderate risk profile. Adverse reactions could potentially interfere with daily life, and attention to their use is required. This is the largest category of OTC drugs in Japan.

• Sub-category: "Designated Class 2 Pharmaceuticals" (指定第二類医薬品 - Shitei Dai-nirui Iyakuhin): Within Class 2, certain drugs are designated as requiring special attention. These may include ingredients with a potential for dependence (e.g., certain cough suppressants containing codeine or dihydrocodeine, albeit in OTC strengths), contraindications for specific populations (e.g., children, pregnant women, elderly individuals), or a higher risk of interactions.
• Examples: Common cold remedies, many analgesics (e.g., those containing ibuprofen, aspirin, or acetaminophen as primary ingredients), antihistamines, and antidiarrheals.
• Sales Regulations:
  • Sales by Pharmacist or Registered Seller: Class 2 Pharmaceuticals can be sold by either a pharmacist or a qualified "Registered Seller" (登録販売者 - tōroku hanbaisha) (PMD Act, Article 36-9, Item 2).
  • Effort Obligation for Information Provision: The pharmacist or registered seller must make an effort to provide information to the purchaser regarding the drug's use and risks (PMD Act, Article 36-10, Paragraph 3). For Designated Class 2 Pharmaceuticals, this "effort obligation" is interpreted more strongly, and active encouragement for consultation is expected. The packaging of Designated Class 2 drugs often carries a prominent warning advising consultation.
  • Mandatory Response to Consultation: If a consumer consults about a Class 2 drug, the pharmacist or registered seller is obligated to provide appropriate information and advice.
  • Display: Class 2 drugs are generally more accessible to consumers on store shelves compared to Class 1. However, Designated Class 2 Pharmaceuticals may have specific display recommendations or requirements, such as being placed within 7 meters of the consultation counter or having clear, prominent labeling of their status.
  • "Specific Sales" (Internet Sales): Permitted. A pharmacist or registered seller must be available for consultation and information provision.

Class 3 Pharmaceuticals (第三類医薬品 - Dai-sanrui Iyakuhin)

These OTC drugs are considered to have the lowest risk profile among the three general classes. Their use is generally not expected to cause significant interference with daily life due to side effects, provided they are used correctly and not in excessive quantities.

• Examples: Vitamin preparations, some digestive aids (e.g., certain antacids or digestive enzyme supplements), mild topical antiseptics, and some traditional herbal medicines with a long history of safe use for minor complaints.
• Sales Regulations:
  • Sales by Pharmacist or Registered Seller: Similar to Class 2, Class 3 Pharmaceuticals can be sold by either a pharmacist or a registered seller (PMD Act, Article 36-9, Item 2).
  • Information Provision: There is no explicit legal obligation to proactively provide information for Class 3 drugs unless the consumer initiates a consultation. However, providing information is considered good professional practice.
  • Mandatory Response to Consultation: If consulted by a consumer, the pharmacist or registered seller must provide necessary information.
  • Display: These drugs generally have the fewest restrictions on in-store display and can be freely accessed by consumers.
  • "Specific Sales" (Internet Sales): Permitted, with the requirement that a system for consultation with a pharmacist or registered seller is available, although the proactive information provision demands may be less stringent than for Class 1 or 2.

"Specific Sales" (特定販売 - Tokutei Hanbai) of OTC Drugs – Internet and Mail-Order

The regulation of "Specific Sales" (which primarily refers to internet and mail-order sales) of OTC drugs has been a significant area of legal development in Japan. A landmark Supreme Court decision on January 11, 2013 (Saikōsai Dai-ni Shōhōtei Hanketsu, Heisei 25-nen (Gyō Hi) Dai 257-gō) found that previous MHLW ordinances that uniformly prohibited internet sales of Class 1 and Class 2 OTC drugs exceeded the scope of delegation under the then-Pharmaceutical Affairs Law and were therefore invalid. This ruling prompted revisions incorporated into the PMD Act, which now provides a legal basis for the specific sale of Class 1, Class 2, and Class 3 OTC drugs, but explicitly prohibits it for Guidance-Requiring Pharmaceuticals.

Key requirements for businesses conducting specific sales include:

• Operation from a Licensed Physical Premise: Specific sales must be conducted from a pharmacy or store that holds a valid physical license. There are rules concerning the relationship between the online sales operation and the physical store, including staffing and the location from which products are shipped (PMD Act Regulations (施行規則 - shikō kisoku), Article 1, Paragraph 2, Item 5). Shipping directly from a warehouse that is not part of the licensed retail site may be subject to restrictions.
• Clear Identification: The website or catalog must clearly display information about the seller, including the name and address of the pharmacy/store, license number, name of the responsible pharmacist or registered seller, and contact details.
• Information Provision and Consultation System: A robust system must be in place to allow consumers to receive information and consult with a pharmacist (for Class 1 drugs) or a pharmacist/registered seller (for Class 2 and 3 drugs) before purchase. This can be via email, telephone, video chat, or other electronic means. The system must ensure the qualifications of the professional providing the advice are clear.
• Online Product Information: Detailed product information, including the risk classification, active ingredients, indications, contraindications, warnings, and an image of the product packaging, must be clearly displayed.
• Confirmation of Understanding (Class 1): For Class 1 drugs, the seller must take steps to confirm that the purchaser has understood the information provided by the pharmacist before finalizing the sale.
• Age Verification/Restrictions: Systems should be in place to prevent the sale of inappropriate OTC drugs to minors.

The Role of Registered Sellers (登録販売者 - Tōroku Hanbaisha)

The "Registered Seller" qualification was formally established to improve consumer access to Class 2 and Class 3 OTC drugs, especially in drugstores and other retail outlets that may not always have a pharmacist on duty, or in areas with a shortage of pharmacists.

• Qualification: Individuals can become registered sellers by passing a prefectural examination. While previously, practical experience was a prerequisite for taking the exam, the requirements have evolved, though practical experience is still crucial for certain roles like store manager.
• Scope of Work: Registered sellers are authorized to sell Class 2 and Class 3 OTC Pharmaceuticals. They can provide information and respond to consultations regarding these two categories. They are not permitted to handle Guidance-Requiring Pharmaceuticals or Class 1 Pharmaceuticals. The presence of registered sellers allows for wider availability of a broad range of OTC products while still ensuring a level of professional oversight.

Implications for Businesses in the OTC Market

The detailed classification system for OTC drugs in Japan has several critical implications for businesses:

• Product Classification Strategy: Correctly classifying a new OTC product (or a product being switched from prescription status) into the appropriate risk category is a fundamental first step and will dictate its entire regulatory and commercial pathway.
• Labeling and Packaging: Packaging and labeling must clearly indicate the risk classification (e.g., 「要指導医薬品」, 「第1類医薬品」, 「第②類医薬品」 for Designated Class 2, 「第2類医薬品」, 「第3類医薬品」) and include all legally mandated warnings and information.
• Sales Channel and Staffing: The choice of sales channels (physical store, internet) and the required staffing (pharmacists, registered sellers) are directly determined by the product's classification.
• Information Provision Systems: Businesses must establish compliant systems for providing information and consultation, both in physical stores and for online sales, tailored to the requirements of each drug class.
• Advertising and Promotion: Marketing activities must adhere to the PMD Act and the "Standards for Appropriate Advertising of Pharmaceuticals, etc.," with restrictions varying based on the OTC category. Claims of efficacy must be appropriate and not misleading.
• Navigating "Guidance-Requiring" Status: For innovative Switch-OTC or Direct-OTC products, successfully managing the initial period as a Guidance-Requiring Pharmaceutical, with its face-to-face sales restriction, is a key strategic challenge that requires careful planning for pharmacist engagement and patient education.

Conclusion

Japan's multi-tiered regulatory framework for Over-The-Counter pharmaceuticals is designed to ensure consumer safety while facilitating access to appropriate self-medication options. The distinctions between Guidance-Requiring Pharmaceuticals, Class 1, Class 2 (including Designated Class 2), and Class 3 drugs are based on a careful assessment of risk, each with corresponding obligations for sellers regarding professional involvement, information provision, and sales channels. For businesses, navigating this intricate system demands meticulous attention to detail, a commitment to compliance, and a strategic approach to product development, marketing, and sales in one ofthe world's most sophisticated OTC markets. Adherence to these regulations is not merely a legal obligation but also a key factor in building consumer trust and ensuring the responsible provision of OTC medicines.