Registration and Importation of Quasi-Drugs in Japan

Introduction:

Japan implements a strict approval system for quasi-drugs. The focus of the approval lies on the efficacy, safety, and quality specifications of ingredients.

Quasi-drugs mainly refer to products added with active ingredients approved by MHLW in a prescribed dose, whose efficacy is between pharmaceuticals and cosmetics and is safe as cosmetics, with no side effects. The most significant difference between quasi-drugs and cosmetics is whether they contain "active ingredients" that claim to have specific efficacies.

Currently, the MHLW divides applications for quasi-drugs into five types, corresponding to different documentation requirements. The first three types pertain to new ingredients. The "qualified quasi-drug" in the fourth type refers to a quasi-drug that is different from an approved quasi-drug but can be judged to be identical to the approved quasi-drug without conducting new tests relating to efficacy and safety. And the "same quasi-drug" in the fifth type refers to a quasi-drug with the same formula but manufactured and sold by different enterprises with different names and packing.

The conditions for successful import or sale of quasi-drugs for foreign manufacturers:

1.??????Select the Japanese importer or seller with the Marketing License of Quasi-drugs

2.??????The foreign manufacturer needs to obtain the "Accreditation of Foreign Quasi-drug Manufacturer";

3.??????Complete product Application and obtain MHWL approval

Note: Product considered “high risk” will need to pass a GMP inspection conducted by PMDA.

Marketing Approval

In addition to the licenses of the relevant enterprises, the product itself shall complete application for marketing approval and obtain the approval from MHLW before entering the market. Whether the product under application can be approved as a quasi-drug depends on whether the use of the product is within the scope of the Pharmaceuticals and Medical Devices Act, according to its ingredient, content, function, efficacy, usage, dosage form, etc.

The necessary review items for quasi-drugs are as follows:

???????Trade name

???????Ingredients and content or traits: the name, content, specification and purpose of ingredients in the product formula

???????Manufacturing process

???????Usage and dosage

???????Function or efficacy

???????Storage method and validity period

???????Specifications and test methods

Timelines

In general, it takes at least 6-8 months for products to be approved by MHLW.

GRP Quasi-Drug Services:

1. Formula/Ingredient Review
2. Support with Formula Development for Japan Market
3. Quasi-Drug Label Development Support
4. PMDA Consultation Support
5. PMDA Inquiry Support
6. Preparation of Marketing Application (Quasi-Drugs)