Registration Process and Requirements for Japanese Imported Quasi-drugs

About Quasi-drugs

Japanese quasi-drugs refer to products with mild pharmacological effects for preventing diseases or alleviating uncomfortable symptoms, falling between cosmetics and medicines. Quasi-drugs is a unique functional product category in Japan, which is permitted to indicate certain specific effects on labels and advertisements, such as:

• Acne-removing toner
• Anti-hair loss shampoo
• Whitening essence
• Antiperspirant
• Sunscreen
• Antibiotic hand sanitizer

Compared with ordinary cosmetics, the registration requirements for Japanese quasi-drugs are more complex, involving multiple aspects such as ingredient review, efficacy limitations, packaging and labelling regulations and compliance management of the responsible party.

The Japanese Quasi-drug Regulatory System

The Ministry of Health, Labour and Welfare (MHLW) is responsible for formulating regulations, setting approval standards and developing the national regulatory strategy for quasi-drugs. The Pharmaceuticals and Medical Devices Agency (PMDA) is responsible for the technical review of application documents, analysis of component safety, etc. Local health bureaus and prefectural governments are responsible for the review of enterprise licenses, inspections of production sites, market supervision, and punishment for violations at the implementation level.

Quasi-drugs Type

General Quasi-drugs Import Registration Process

• Step 1: Verify whether the product's efficacy and ingredients meet the "General quasi-drug" standards

• Whether the active ingredients are included in the ingredient list published by MHLW
• Whether the ingredient concentrations are within the permitted range
• Whether the label and advertisement content is limited to the permitted efficacy range

If new ingredients are included or the efficacy is not clearly defined, then registration should be carried out according to the "New Quasi-drugs" path, with a significantly increased cycle and difficulty.

• Step 2: Designate a Marketing Authorization Holder (MAH)

All imported quasi-drugs must designate a local Japanese enterprise as Marketing Authorization Holder (MAH), responsible for registration, declaration, market supervision, recall and other duties. The MAH must hold the following qualifications:

• Quasi-drug marketing license
• If there are own warehouses or labeling processes, a manufacturing or packaging labeling license is also required.

Enterprises can establish their own legal entities, or entrust qualified third-party registration agencies, trading companies or OEM manufacturers.

• Step 3: Prepare registration materials

• Application form (in the format prescribed by MHLW)
• Product specification manual (ingredients, concentrations, usage methods, dosage forms, pH, odor, color, etc.)
• Test data (microbial limit test, stability test, safety literature support)
• Manufacturer information (GMP certification of the origin factory and production process description)

• Step 4: Submit the application

The MAH submits all materials to PMDA or the local health bureau to apply for registration and obtain an approval number. During the registration process, PMDA may require supplementary test data or ingredient descriptions.

The registration period is generally 4-12 months, depending on whether the product ingredients are sensitive, whether the materials are complete, and the progress of the review.

• Step 5: Obtain the quasi-drug approval number

After the review is passed, a product-specific quasi-drug approval number will be issued for the product. This number must be printed on the product label to allow official import and sale.

Key Compliance Points for Import & Sales

Label and Packaging Requirements

The packaging of quasi-drugs must comply with Japanese regulations. The labels must not use words such as "cure", "effective", or "remarkable efficacy". The product packaging must include the following Japanese information:

• Product name
• Quasi-drugs lettering and approval numbers
• Function and usage
• Usage methods and precautions
• MAH and contact information
• Batch number, expiry date, place of origin, etc.

Customs Declarations and Quarantine Requirements

The enterprise is required to provide the approval number, product manual, origin certificate, invoice, etc., and attach the ingredient list (in English or Japanese version). If customs discovers non-compliant labels or formulas, it may prohibit the product from entering the country or require its return.

Responsibilities After Market Launch

• Establish a product tracking and recall mechanism
• Report severe adverse reactions or complaints
• Accept supervision actions such as random inspections and on-site examinations by local health authorities
• If there is false promotion or ingredient over-limiting, the enterprise may be ordered to remove the product, fined, or have its license revoked, etc.

Our Services

As a leading compliance service provider, Proregulations closely monitors and conducts in-depth research into the regulatory changes and industry trends in Japanese quasi-drugs. We advise companies to thoroughly understand the relevant regulations before entering the Japanese market, and to reasonably plan the product efficacy, label content, and registration path. On the other hand, companies can collaborate with qualified local institutions to reduce communication costs and review risks, thereby enhancing the competitiveness and trustworthiness of their products on the Japanese market.

Proregulations assists clients in promptly adjusting and optimizing their product launch strategies based on the latest regulations and guidance documents in Japan. We offer the following services related to quasi-drugs registration:

• Regulatory interpretation and standard understanding
• Regulatory consultation and training
• Product registration path planning
• Component review and efficacy confirmation
• Registration document preparation
• Labelling and advertising compliance check
• Market supervision support
• Risk analysis

Proregulations is dedicated to assisting global enterprises in successfully entering the high-end skincare and cosmetic medicine market in Japan. If you are interested in our services, please contact us.

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