Regulatory differences and similarities: systems in Japan.

The historic steps that led up to the present federal drug regulations in the United States are outlined as a background to the development of the current drug regulatory system in Japan, consisting of the procedures for approval of new drugs, of double-brand naming, by which the same drug under different names can be sold as ethical or over-the-counter (OTC). The more recent provisions for re-evaluation of drugs, the mechanism for monitoring adverse reactions, and the dissemination of the collected information are described. The prescription habits of physicians, the influence of the health insurance systems on these, and the strikingly high level of drug consumption in Japan, as compared with those in other industrial countries, are discussed and illustrated graphically.