Japanese Pharmaceutical Affairs Bureau

Aminophenazone (amidopjrine) is the most toxic and most dangerous anti-inflammatory analgesic. Blood dyscrasias have been documented beyond any doubt, perhaps due to a hypersensitivity mechanism. The Committee on the Safety of Drugs of the Japanese Pharmaceutical Affairs Bureau has ordered its withdrawal because of its serious adverse effects (SEDA-12, 82) and it has been withdrawn in most developed countries. However, aminophenazone is still used in some developing countries (1). 

Japanese Pharmaceutical Affairs Bureau, Pharmaceutical Administration in Japan, 5th Edition (Tokyo, Japan Yakuji Nippo, Ltd., 1991). 

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. 

Koseisho (1988), Good Laboratory Practice Attachment GLP Inspection of Computerised Systems, Pharmaceutical Affairs Bureau, Japanese Ministry of Health and Welfare, Tokyo. 

Notification No. 698, Pharmaceutical Affairs Bureau, Japanese Ministry of Health and Welfare, Tokyo, 1980. Draft Policy to Handle Stability Data Required in Applying for Approval to Manufacture (Import) Drugs and Draft Guidelines on Methods to Perform Stability Test. Ministry of Health and Welfare The First Evaluation and Registration Division, Pharmaceutical Affairs Bureau, 1990. 

In order to clarify the following sections, some regulations have been artificially separated. For Western people not familiar with Japanese regulations, these rules, delivered through hundreds of notifications from the Pharmaceutical Affairs Bureau, are a huge maze. We have tried to simplify this review, and we apologize for the lack of precision consequently induced. 

JAN (Japanese Accepted Names) (Japanese Ministry of Health and Welfare, New Drugs Division, Pharmaceuticals Affairs Bureau, 1-2-2, Kasumigaseki, Chiyoda-ku, Tokyo 100, Japan). 

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. 

The Pharmaceutical and Medical Safety Bureau (PMSB) has primary responsibility within the Japanese Ministry of Health, Labour and Welfare for administering the requirements established for the safety and efficacy of medical products under Japan s Pharmaceutical Affairs Law. This legislation was substantially amended in 1996 (with the reforms made effective in April 1997) to provide for the present medical product review and approval system. 

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