Quasi Drug Rules in Japan

December 2011

Quasi-drugs are a unique product classification in Japan. A quasi-drug is defined in Japan as products that have minimal to moderate pharmacologic activity but are restricted in use to specific indications¹. Quasi-drugs in Japan include catagories of products that are often defined as drugs, cosmetics or Over-the-Counter (OTC) products in other regions. Products in this class include some energy drinks containing taurine, some vitamin preparations, hair tonics, bath preparations, skin whitening products, acne products, anti-dandruff shampoos, fluorinated toothpaste, hair dyes and many others. These products are considered borderline medicinal products, which are categorized differently in various markets.

Manufacturers of quasi drugs need to be accredited by the Minister of Health, Labor and Welfare (MHLW)² according to Article 13-3 of the Japanese Pharmaceutical Affairs Law (PAL). This applies to domestic manufacturers as well as to foreign manufacturers when importing products into Japan. Essentially this means that in Japan such products must be manufactured under cGMP conditions and supply chain managed in a similar way as a drug product.

Additionally a premarketing approval of all quasi-drugs is required by the Pharmaceutical and Food Safety Bureau of the MHLW applies according to Article 14 of the PAL. For the application of the marketing approval a foreign manufacturer must appoint a drug marketing authorization holder (MAH) in Japan who performs all procedures with the MHLW on behalf of the applicant. The MAH can as well apply for the manufacturing license of the manufacturer and is also authorized to market the products. All summary documentation and forms filed for the market authorization applications is required to be submitted in Japanese.

The MAH must also comply with all regulations for the holder of a market authorization for a drug in Japan. This means that the MAH must have a quality representative, medical safety officer and General Manager who are qualified to take responsibility for release of the medicinal product in Japan.

The regulatory agency conducting the scientific reviews for the marketing approval is the Pharmaceuticals and Medical Devices Agency (PMDA)³, which also monitors the post marketing safety. Recently the PMDA has translated many of their key regulations and guidelines into English to facilitate interactions with foreign companies.

The information required for the marketing approval for a quasi-drug is similar to that of a new drug product. This information includes detailed information on the quality and controls of the ingredients, manufacturing information, stability, storage conditions, expiration date, and quality controls. Additionally, a detailed description of the manufacturing sites of the ingredients and of the drug should be provided⁴.

All ingredients of a quasi drug must have a monograph in the Japanese Pharmacopoeia5 and comply with the given criteria. They must have an active ingredient declared and when the active ingredient is used within the dosage that was previously approved for other products, the marketing authorization typically takes approximately 8 months. However, when the dose of the active ingredient is higher than previously approved, additional nonclinical data to evaluate the safety, efficacy and stability of the product may need to be provided which requires a lead-time of approximately 2 years. Changes to the product after approval are completed as an amendment to the market authorization and can take from two weeks for very simple modifications to more than 8 months for major changes⁶. Although, when compared to cosmetics, the pre-marketing steps for quasi-drugs are more extensive, marketing of the product is similar and quasi-drugs are sold without prescription or restrictions in distribution.

Quasi-drugs also have restrictions with regards to the volume of the product sold to limit the exposure to consumers. As such, quasi-drug products cannot be sold in volumes of greater than 100 mL in volume. The labeling must also carefully comply with requirements for quasi-drugs and must provide the consumer with an understanding of what the product contains, the purpose and appropriate dosing instructions. The information must be factual without exaggeration and must be clearly stated on the container or box the container is held in when sold. The requirements for the labeling under the Pharmaceutical Affairs Law are:

1. Name and address of manufacturer
2. Product Trade Name
3. Manufacturers serial number or manufacturing code
4. Listing of all ingredients
5. Weight or volume of the unit of use
6. Expiration date
7. Category name
8. Warnings regarding use and handling
9. Description of the container

In conclusion, the system for distribution of some products, now called quasi-drugs, in Japan was relaxed in 2004. However, those products that are defined as quasi-drug products are still subject to significant regulatory control. While these products are sold directly to the consumer, they must be approved by the MHLW and must meet requirements similar for medicinal products. However, the system in Japan also allows for wide distribution of some products with few limitations on the ability to sell the products to consumers. Thus, the market for quasi-drugs is attractive for many companies, both domestic and foreign, and represents a large market opportunity for these products in Japan.

Richard E. Lowenthal, MSc MBA
Pacific-Link Consulting LLC (San Diego and Tokyo)
JETRO North America Health Care Advisor

References

¹http://www.mhlw.go.jp/english/topics/import/
²http://www.mhlw.go.jp/english/index.html
³http://www.pmda.go.jp/english/about/who.html
⁴http://www.pmda.go.jp/english/service/pdf/notifications/Guideline...
⁵http://jpdb.nihs.go.jp/jp15e/