ABSTRACT

Regulatory Environment 643

Cosmeceuticals in Japan 650

Cosmeceuticals in the Future 651

References 652

REGULATORY ENVIRONMENT

The legal classification of topical products in Japan is different from that in the

USA and Europe, where they are classified into only two categories-drugs

and cosmetics. In Japan, there are also regulations covering cosmetic products

with pharmacological action, called quasidrugs, which are ranked between

cosmetics and drugs (1). Each definition of drugs, cosmetics, and quasidrugs in

the regulations of The Pharmaceutical Affairs Law (2,3) reads as follows.