Pharmacol Res. 2000 May; 41(5): 515-9.

Regulation of herbal medicines in Japan.

Saito H.

Department of Pharmacology, College of Pharmacy, Nihon University, Funabashi-shi, Chiba, Japan.

In Japan, two overlapping types of traditional herbal medicines coexisted for centuries. The first one was the traditional Japanese and Chinese medicine. These medical systems were damaged by the first Medical Care Law in 1874 that proclaimed the abrogation of traditional Japanese medicine. The second type of herbal medicine used in Japan originated in Europe and south-east Asia and became popular after the law in 1874 was announced. Some of those products are still used today as prescription drugs. Although the renaissance of the traditional medicines has been on the rise since approximately 1960, the confusion and decline of the traditional Japanese medicines was further strengthened by introduction of dietary supplements. Regulation of herbal medicines, except 'Kampo' formulas is the same as the approval for both prescription and OTC drugs. Typical characteristics of the Japanese herbal medicines is the existence of Japanese traditional medicines, 'Kampo' formulas and combinations of the traditional medicines with vitamins and pharmaceuticals. Regulation of quality standards of those herbal products was established in Japanese Pharmacopoeia for more than 90% of them.Copyright 2000 Academic Press.