Regulatory Environment

The cosmetic regulations in Japan are extensive and complex [1]. The legal classification of topically applied products is different from the United States and the European Union, where they are divided into only two categories: drugs and cosmetics. In Japan, there are additional regulations covering cosmetic products with pharmacological action, called quasidrugs, which are ranked between cosmetics and drugs [2]. Under the Pharmaceutical Affairs Law, cosmetics, as well as drugs and quasidrugs, are also subject to premarket clearance by the Ministry of Health and Welfare (MHW) [1]. The definitions of drugs, cosmetics, and quasidrugs in the regulations [3] read as follows:

Drugs are defined as:

1. Articles recognized in the official Japanese Pharmacopoeia.

2. Articles (other than quasidrugs) that are intended for use in the diagnosis, cure, or prevention of disease in man or animals, and that are not equipment or instruments (including dental materials, medical supplies, and sanitary materials).

3. Articles (other than quasidrugs and cosmetics) that are intended to affect the structure or any function of the body of man or animals, and that are not equipment or instruments (Paragraph 1, Article 2 of the Law).

Quasidrugs are articles that have the purposes given as follows and exert mild actions on the human body, or similar articles designated by the Minister of Health and Welfare. They exclude not only equipment and instruments, but also any article intended, in addition to the following purposes, for the use of drugs previously described in (2) and (3).

1. Prevention of nausea or other discomfort, foul breath, or body odor. j

2. Prevention of prickly heat, sores, and the like.

3. Prevention of hair loss, restoration of hair, or depilation of unwanted hair.

4. Killing or prevention of rats, flies, mosquitoes, fleas, etc. for maintaining the health of man or animals (Paragraph 2, Article 2 of the Law).

Quasidrugs designated by the Minister of Health and Welfare (Notification No. 14, 1961), include cotton products intended for sanitary purposes (including paper cotton), as well as the following products with a mild action on the human body:

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