Clinical research organizations Japan

Clinical Research Center for Allergology and Rheumatology, National Hospital Organization, Sagamihara National Hospital, 18-1 Sakuradai, Minami-ku, Sagamihara, Kanagawa, Japan (139)... 

The Japanese pharmaceutical industry traditionally was largely domestic. Japanese firms did little innovative R D and thus did not produce many new drugs for potential introduction into other countries, nor did foreign companies market their own drugs in Japan. This situation, now changing, reflected Japanese trade policies, the organization of Japanese medicine, and principles governing Japan s clinical research requirements. 

Both the DSM-IV (American Psychiatric Association, 1994) and the ICD-10 (World Health Organization, 1993) are used in Japan, with the latter being the official system used to record diseases and the former preferred in research, including for clinical studies on psychotropics. No Japanese version of a structured or semistructured interview scheme based on either the DSM or ICD system for children is yet available. 

Drug approval processes go through IND and NDA procedures in Japan. The MHLW of Japan has set up the Organization for Pharmaceutical Safety Research (OPSR), which provides technical consultation services for clinical trials. There are four types of consultations before IND, at end of Phase II studies, before NDA, and consultation on individual protocols. 

The research led to the 6-fluoro structure 3, norfloxacin (Figure 2), which combined favorable antibaaerial properties and other characteristics. Depending on the organism, minimum inhibitory concentrations were improved up to 500-fold over nalidixic acid. The spectrum of activity was extended to Pseudomonas. This compound and the many other 6-fluoroquinolones diat have since reached the market have been successful in achieving clinical efficacy rates of about 90%. Norfloxacin is marketed in Japan, the United States, and other countries. 

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