Ministry of Health and Welfare

The Japanese regulatory authority is the Ministry of Health and Welfare (MHW) and the Pharmaceutical and Medical Safety Bureau (PSMB) is responsible for the promulgation of national and international guidelines in the form of Notifications. Guidelines are available on the Internet web-site of the National Institute of Health and Science (http //www.nihs.go.jp). The MHW has not issued specific guidance on the development of chiral drugs, but has nonetheless responded to the enantiomer-versus-racemate scientific debate. The attitude of the MHW and its advisory body, the Central Pharmaceutical Affairs Council (CPAC) is discussed in two articles by Shindo and Caldwell published in 1991 and 1995 [17, 18]. The latter paper analyzes the results of a survey of the Japanese pharmaceutical industry which sought responses on chirality issues. 

This work was supported in part by Grants-in-Aid for Cancer Research from the Ministry of Education, Science and Culture, a grant for the Program for a Comprehensive 10-Year Strategy for Cancer Control from the Ministry of Health and Welfare of Japan, grants from the Foundation for Promotion of Cancer Research, the Princess Takamatsu Cancer Research Foundation, and the Smoking Research Foundation., and by Grant CA 12623 from the National Institutes of Health. 

One in eight Japanese hospitals accepted a prospective tariff per type of disease. . . the amount of drugs supplied to inpatients decreased by 83 per cent. Japanese doctors prescribed and dispensed the drugs. .. the Ministry of Health and Welfare wants to put a stop to this practice. 

Food in the EU as well as by the Ministry of Health and Welfare in Japan to be used in food contact applications. Therefore, it is not expected that a clearance for the use of poly(HAMCL) latex in cheese coatings will be a bottleneck. 

The Japanese are the greatest consumers of pharmaceutical products per capita in the world. The Ministry of Health and Welfare in Japan has overall responsibility to implement Japanese pharmaceutical law. Within the department is the Pharmaceutical Affairs Bureau (PAB), which exercises this authority. 

The average limit of a tolerable daily intake (TDI) fixed by the World Health Organization (WHO) is 0.5 i-g kg-1 day-1 for triphenyltin and this figure corresponds to a permissive concentration in fish of 0.25 pg g 1. TDI of 1.6 pgkg-1 day-1 for tributyltin oxide is assessed by the Ministry of Health and Welfare, lapan66. 

Japanese Ministry of Health and Welfare (Former Ministry of Health, Labor and Welfare), Guidelines for Toxicity Studies of Drugs (7) Skin Photosensitization Studies, Tokyo,... 

Japan Ministry of Health and Welfare Japanese Pharmaceutical... 

JMHW (1984). Guidelines for Testing of Drugs for Toxicity. Pharmaceutical Affairs Bureau, Notice No. 118. Ministry of Health and Welfare, Japan. 

Joint Directives of the Japanese Environmental Protection Agency, Japanese Ministry of Health and Welfare and Japanese Ministry of International Trade and Industry, 31 March 1987. 

Japanese Ministry of Health and Welfare (MHW). (1989). Revised Guidelines for Toxicity Studies Required for Application for Approval of Manufacturing/Importing Drugs. Ministry of Health and Welfare Tokyo, pp. 37—48. 

Note GLP = Good Laboratory Practice ICH = International Conference on Harmonization IND = Investigational New Drug JMHW = Japanese Ministry of Health and Welfare MAA = Marketing Authorization Application NCE = New Chemical Entity. 

Environmental Health Bureau, Ministry of Health and Welfare. "Food Hygiene Inspection Manual" Food Hygiene Association Tokyo, 1978 pp. 232-240. 

Standard Methods of Analysis in Food Safety Regulations. Analytical Methods for Food Additives in Food, Ministry of Health and Welfare, Nihon Shokuin Eisei Kyoukai, Tokyo, Japan, 1989, pp. 68-71. 

The Pharmaceuticals and Cosmetics Division (Koseisho) of the Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare (MHW) is the regulatory body in Japan. Also in Japan there have been clear changes in the drug approval system, mainly inspired by ICH. One of the most important recent changes is that, under certain conditions, it is now possible to use also foreign data for the approval of new dmgs in Japan. 

In Japan, all drugs need approval for their clinical use by the Ministry of Health and Welfare, on the basis of their being proven safe and effective through at least... 

In 1997, the Ministry of Health and Welfare extensively reformed the drug evaluation system and established the Pharmaceuticals and Medical Devices Evaluation Center affiliated with the National Institute of Health Sciences. Under the new system, the Center, through its specialized teams, conducts the evaluation of drugs for which different pharmaceutical companies have sought approval. 

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