Pharmaceutical Affairs Bureau

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. 

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

General Guidelines (Draft) for Clinical Evaluation of New Pharmaceuticals. Tokyo Pharmaceutical Affairs Bureau of the Ministry of Health Welfare, 1988. 

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. 

Ministry of Efealth, Labor, and Welfare, Japan (MEfLW) The unit responsible for the improvement and promotion of social welfare, social security, and public health is the Pharmaceutical Affairs bureau of the ministry. It is one of the nine bureaus within the Pharmaceuticals and Cosmetics Division and is responsible for review and licensing of all medicinal products and cosmetics. In Japan, it acts as the focal point for ICH activities. Technical advice on ICH matters is obtained through MHLW s regulatory expert groups. 

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

In Japan, the Pharmaceutical Affairs Bureau (PAB) within the Ministry of Health and Welfare (MOHW) (see Ref. 20 for a description of its organization and functions) has also not yet issued formal guidelines on the approval of racemic drugs. Indeed, no formal guidelines may be prepared on this issue. As recently discussed by Shindo and Caldwell (21),... 

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. 

Several standards are published as advisements from the Pharmaceutical Affairs Bureau that set voluntary standards for various pharmaceuticals to ensure and improve their quality. Because the standards and specifications in these guides are voluntary, there is no overlap with the JP monographs. 

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). 

Following reports of colonic necrosis, the Pharmaceutical Affairs Bureau of Japan has revised the product information for enemas of polystyrene sulfonate cation exchange resin suspension in sorbitol solution for potassium removal (31). Although a causal relation has not been established definitively, the Bureau has decided that sorbitol solution should not be used for enemas of sodium polystyrene sulfonate cation exchange resins. 

Anonymous. Mucormycosis induced by deferoxamine mesylate. Information on Adverse Reactions to Drugs. Japan Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, February 1988. 

Ethical drugs are ones being supplied for use by physicians or dentists or under the prescription/direction of a physician or dentist (Notification No. 483 of the Pharmaceutical Affairs Bureau/PAB, 1980). 

The name of the former Pharmaceutical Affairs Bureau (PAB) is ch2mged to the Pharmaceutical and Medical Scifety Bureau (PMSB). But it is Ceilled the PAB in this Chapter. 

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). 

NCRR —National Center for Research Resources PAB —Pharmaceutical Affairs Bureau (Japan)... 

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

Note—Japan Pharmaceutical Affairs Bureau Notification covers ophthalmics. 

Japan Pharmaceutical Affairs Bureau Notification 958. Testing Methods for Plastic Containers. 

Pharmaceutical Affairs Bureau Ministry of Health and Welfare 122 Kasumigaseki, Chiyoda-ku Tokyo 100-45 Tel 81 3 35919646 Fax 81 33597 9534... 

Pharmaceutical Affairs Bureau Ministry of Health and Welfare 1, Chungong-dong... 

The core administration, which consists of the Secretariat (including the Statistics and Information Department) and nine bureaux, as follows Health Policy Bureau Health Service Bureau Environmental Health Bureau Social Welfare and War Relief Bureau Health and Welfare for Elderly Bureau Children and Families Bureau Health Insurance Bureau Pension Bureau and the Pharmaceutical Affairs Bureau which plays a major part in drug regulation. Around 2000 officials work full-time in the central offices. 

The Pharmaceutical Affairs Bureau, with the assistance of the Central Pharmaceutical Affairs Council (CPAC) and the Organization for Adverse Reaction Drug (ADR) Relief, Research and Devel-... 

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