ABSTRACT
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).
