In the Pharmaceutical Affairs Law, quasidrugs are defined as articles having ''fixed purpose of use'' and ''mild action on the body,'' or similar articles designated by the Minister of Health and Welfare. Most of the products in this category are what we call ''pseudo-drugs'' or ''cosmeceuticals,'' a current definition of which would be ''those products that will achieve cosmetic results by means of some degree of physiological action'' [8]. The defined quasidrug products include mouth refreshers, body deodorants, talcum powders, hair growers, depilatories, hair dyes, permanent waving products, bath preparations, medical cosmetics (including medical soaps), medicated dentifrices, and so on [3,9].

At each stage of development, manufacture/import, distribution, and use, the prescribed regulations are enforced [3]. Manufacturers of quasidrugs are required to obtain government approval before marketing. Approval of a product under an application for manufacturing/importing is the responsibility of the MHW. Is it adequate as a quasidrug in view of its efficacy, safety, etc.? Therefore, the examination procedures for approval as well as the data and documentation required to be submitted for filing an application

differ with the indications and effects of each product [3]. The following data must be attached according to the kind of ingredients employed, and so on:

• Origin, background of discovery, use in foreign countries, etc.

• Physicochemical properties, specifications, testing methods, etc.

• Indications or effects

The scope of the data to be attached to the application depends on the type of quasidrug; (1) new quasidrugs that obviously differ from any previously approved products with respect to active ingredients, usage and dosage, and/or indications or effects; (2) quasi-drugs identical with previously approved quasidrug(s); or (3) other quasidrugs that are other than those specified in (1) and (2) [3].

All products for approval as a quasidrug must be within the scope stipulated by the Pharmaceutical Affairs Law. Thus, approval of a product as a quasidrug is determined by an integrated judgement of various factors such as its ingredients, quantity (composition), indications and effects, usage and dosage, and dosage form. For example, those products whose effects are not mild—hence, coming under the category of poisons or deleterious drugs—are not approved even if their indications and effects and dosage forms are within the scope of the quasidrugs legislation. Likewise, products for which the intended use deviates from the scope of quasidrug are also not approved even if their effects are mild [3].

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