The market

Traditional medicine in Japan may be divided into folk medicine and Kampo medicine, i.e., Chinese medicine from ancient China. Herbal medicines have been used effectively in Japan for the past 1,400 years and similar to the situation in China, today raw medicinal herbs used as folk medicine are combined with modern preparations in many cases. The per-capita consumption of herbal medicine in Japan is the highest in the world with among the top 100 items of OTC drugs sold, 45 correspond to the raw herb combined preparations representing 34% of sales with considerable economic importance. Kampo drugs are extremely popular in Japan and each Kampo drug is a formula consisting of 5–10 different herbs. Since 1957, several original formulae of Kampo drugs are being produced in modern ready-to-use industrialized granular, powdered forms based on the classic decoction. Today more than 95% of Kampo drugs used in Japan are taken in such ready-to-use forms as ethical drugs.

Legal status

Since 1961, 100% of the Japanese population has been covered by the National Health Insurance (NHI) and in 1972 Ministry of Health Labour and Welfare (MHLW) designated 210 formulas as OTC drugs based on the experience of doctors practising Chinese galenical medicine. In 1976, 43 Kampo drugs were included in the NHI Drug Price Tariff as prescription drugs and today 147 Kampo drug preparations available as ethical drugs are already registered by the MHLW without the need for clinical validation studies.