Japan Pharmaceutical Affairs

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

Note—Japan Pharmaceutical Affairs Bureau Notification covers ophthalmics. 

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

Japan Pharmaceutical Affairs and Food Sanitation Council of the Ministry of Agriculture, Forestry and Fisheries MAFF/PAFSC Pharmaceutical Affairs Law... 

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. 

An NDA submitted to the MHLW is reviewed by the PMDA. PMDA personnel have the authority to inspect the drug manufacturing facility and clinical trial sites to assess comphance. In the process, the PMDA consults the Pharmaceutical Affairs and Food Sanitation Council (PAFSC). Results of the review are forwarded to the Pharmaceutical and Food Safety Bureau (PFSB), which prepares the final approval through the Minister of the MHLW. Figure 8.10 shows the drug approval process in Japan. The procedure for manufacturing and distribution of drugs for overseas manufacturers is presented in Fig. 8.11. 

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. 

In Japan, the principal legal regulations dealing with feed additives and veterinary drugs is the Pharmaceutical Affairs Law established in 1960. Table 11.10 summarizes the compounds currently regulated as medicinal or feed additives by the Pharmaceutical Affairs Law and the Law Concerning Safety Assurance and Quality Improvement of Feed in Japan (74). 

The Ministry of Health, Labour and Welfare is the governmental body responsible for enacting legislation for pharmaceutical affairs. The regulation of clinical trials and new drug approval in Japan is based on the Pharmaceutical Affairs Law and related ordinances. The objective of the Ministry is to secure a safe medical environment through a consolidated structure of accurate reviews of pharmaceuticals and medical devices and postmarketing safety measure implementation. 

The Chemical Substances Control Law regulates chemical substances produced by chemical reaction excluding natural products. However, articles and substances regulated by other laws, such as the Food Sanitation Law in Japan and the Pharmaceutical Affairs Law, and exclusively used for the purposes covered by such laws, together with substances used for research and development, are also exempt from the Law. 

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),... 

In Japan, if the drug product contains an excipient with no precedence of use in that country, then the quality and safety attributes of the excipient must be evaluated by the Subcommittee on Pharmaceutical Excipients of the Central Pharmaceutical Affairs Council concurrently with the evaluation of the drug product application. Precedence of use means that the excipient has been used in a drug product in Japan, and will be administered via the same route and in a dose level equal to or greater than the excipient in question in the new application. 

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. 

In Japan, the Pharmaceutical Affairs Law 1960, as amended, and the Standards for Fair Advertising Practices concerning Medicinal Products define the standards for marketing practices with respect to medicinal products. The Fair Competition Rules were established by the Japan Fair Trade Commission, in accordance with the Law for Preventing Unjustifiable Extra or Unexpected Benefit and Misleading Representation. 

Cases of a serious offence against the Pharmaceutical Affairs Law and the Fair Competition Rules are subject to criminal sanction (i.e. up to 2 years in jail and/or a fine of up to 1 million yen). Such serious sanctions against a company, together with a public announcement, would place the company at a considerable disadvantage with respect to its business in Japan. 

Japanese pharmaceutical administration has a long story it started during the reign of Emperor Meiji, a period during which Japan reopened its frontiers to Western countries. The first law, enacted in 1874, dealt with pharmaceutical sales and handling, but it was limited to three areas (Tokyo, Osaka and Kyoto). Fifteen years later, the law covered the whole country and was merged with another law,-the Patent Medicine Law, in 1925 it was then renamed the Pharmaceutical Affairs Law in 1943. 

The Japan Federation of Medical Devices Associations. 2004. The Pharmaceutical Affairs Law - New Regulations Effective in 2005. Yakuji Nippo Tokyo. 

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). 

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