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.