Japan drug development

Japan Pharmaceutical Manufacturers Association. New Drug Development and Approval Process, http //www.jpma.or.jp/12english/guide industry/new drug/new drug.html [accessed August 8, 2002]. 

Drugs, such as bleomycin, aclacinomycin and deoxyspergualin, were discovered by the Umezawa group at the Institute of Microbial Chemistry in Japan and developed in collaboration with the NCI a number of the agents currently in advanced precUnical development at the NCI, such as UCN-01, and quinocarmycin and spicamycin analogs (Fig. 4), are the result of collaborations between Japanese companies, such as Kyowa Hakko Kogyo, Fujisawa Pharmaceutical Co. Ltd, and IQrin Brewery Ltd, and the NCI. ... 

With the enforcement of the revised PAL and relevant regulations, ICH harmonization and globalization of drug development will bring a new era for drug development and reviewing system of NDAs so that Japan will become a full member of the countries in the long run. 

Differences in preferred dose form, availability of suppositories in France, injections in Italy, pills in the United Kingdom and polypharmacy in Japan, reflect medical practice, education and practice conditions. There is great emphasis and concern in Germany over the heart and diet in France over the liver in the United Kingdom over viruses and in the United States over hypertension and obesity. Only in 1999 were oral contraceptives approved in Japan, a brave action, for it may increase the falling rate of Japanese population replacement, shared with Italy and Western nations (excluding the United States). All reflect a different but small emphases on drug development. 

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