Sakuma A
Clin Pharmacol Ther. 1976 May;19(5 Pt 2):694-9. doi: 10.1002/cpt1976195part2694.
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.
作为日本当前药品监管体系发展背景，概述了美国现行联邦药品法规之前的历史进程，包括新药审批程序、双品牌命名程序（通过该程序，同一药物可采用不同名称作为处方药或非处方药销售）。还介绍了药品重新评估的最新规定、不良反应监测机制以及所收集信息的传播情况。讨论并以图表形式说明了医生的处方习惯、医疗保险体系对其的影响，以及与其他工业国家相比，日本显著高的药品消费水平。
