Japanese Pharmaceutical

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 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. 

Japan Ministry of Health and Welfare Japanese Pharmaceutical... 

JMAFF Japanese Ministry of Agriculture, Forestry, and Fishery JPMA Japanese Pharmaceutical Manufacturers Association... 

The main players at ICH are now the European Commission/EMEA, EEPIA, Japanese Ministry of Health Labour and Welfare (MHLW), Japanese Pharmaceutical Manufacturers Association (JPMA), US FDA and Pharmaceutical Research and Manufacturers of America (PhRMA). The WHO, Canadian Health Protection Branch and the European Free Trade Area (BETA) countries enjoy an observer status at ICH meetings. 

There is serious shortage of medically qualified personnel in Japanese pharmaceutical companies, or worse is the fact that they do not recognise the importance of such expertise in-house. The new GCP requires sponsoring companies to either employ or contract medical professionals in order to obtain medical advice in preparing protocols and conducting clinical trials. 

Japanese Pharmaceutical Excipient Directory. Japanese Pharmaceutical Excipient Council (JPEC), ed. Tokyo Yakuji Nippon Ltd, 1996. 

The International Pharmaceutical Excipient Council in the United States (Arlington, Virginia 703-521-3338) has issued a GMP guideline for excipient bulk pharmaceutical chemicals. In conjunction with both the European and Japanese Pharmaceutical Excipient Councils, the council is currently engaged in establishing international harmonization excipient monographs for the more popular pharmaceutical excipients. A list of important and popular pharmaceutical excipients is given in Table 1. 

Although swab assays are different conceptually than both the impurity and the potency assay, the same scientific rationale governs the development of these assays. Many of the references listed in Table 15.4 outline different validation approaches. Seno outlined validation practices in the Japanese pharmaceutical industry for cleaning verification,23 and Kirsch outlined an approach for swab method validation that is consistent with ICH guidelines for method development.24 An important aspect of any cleaning-verification assay begins with swabbing the... 

ANALYSIS OF DATA FROM THE JPMA QUESTIONNAIRE SURVEY REGARDING ICH S6 IMPLEMENTATION IN JAPANESE PHARMACEUTICAL COMPANIES... 

The International Conferences was jointly supported and organized by the Commission of the European Communities (CEC), the US Food and Drug Administration (FDA), the Japanese Ministry of Health and Welfare (MHW), together with the pharmaceutical industry, as represented by the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), the European Federation of Pharmaceutical Industry Associations (EFPIA), the US Pharmaceutical Manufacturers Association (PMA) and the Japanese Pharmaceutical Manufacturers Association (PMA). 

The virtual company strategy is used by companies, mostly biotechnology firms and many United States and European subsidiaries of Japanese pharmaceutical firms, that do not have the infrastructure or resources to conduct GLP-regulated... 

Similar results are reported in the literature when Kollidon VA 64 is compared to povidone (Kollidon K 25, K 30, and 90 F). Copovidone absorbs about three times less water than the other soluble Kollidon K 25, 30, and 90F after seven days at 25 °C up to 80% relative humidity [62], Kollidon VA 64 is manufactured by free-radical polymetization of 6 parts of vinylpyrrolidone and 4 parts of vinyl acetate in 2-propanol. A water-soluble copolymer with a chain structure is obtained. In contrast to the soluble grades of Kollidon, the number 64 is not a K value but the mass ratio of the two monomers, vinylpyrrolidone and vinyl acetate. The K value of Kollidon VA 64 is of the same order of magnitude as that of Kollidon 30. Synonyms for Kollidon VA 64 are copovidone, copovidonum, copolyvidone, copovidon, and PVP-VAc-copolymer [Eur. Ph., Japanese Pharmaceutical Excipients, and USP National Formulary (NF)] [63],... 

Japanese Pharmaceutical Manufacturers Association (2002), Guideline for the Application of ERES in Production Control and Quality Control for Human Drug Manufacturing. 

In 1992, the pharmaceutical manufacturers of Tokyo and Osaka, the Japanese Pharmaceutical Manufacturer s Association (JPMA) sent a questionnaire to all of... 

The ICH document (1) offers users a choice of any of five different options. Table 1 is a listing of these options. These options arose from the results of a Japanese Pharmaceutical industry survey (2). No effort was made to determine which procedure was best. These results were presented to the QIB Expert Working Group (EWG). The ICH EWG accepted what the Japanese had done and, after debate, adopted it as their guideline. 

Figure 1 presents the spectral power distributions (SPDs) of the various lamps cited in the ICH document and used in the Japanese Pharmaceutical industry. One should note the difference between these lamps and the standard also presented there. 

A. Kawahara, "Present and future aspects of the Japanese Pharmaceutical Affairs Administration," Drug. Inform. 24 153-167 (1990). 

JPMA (Japan) Japanese Pharmaceutical Manufacturing Association [30]... 

Additional non-synthetic colors may be acceptable for pharmaceutical applications based on previous precedence of use. These colors are typically listed in the Japanese Pharmaceutical Excipients (JPE) Directory along with their Japanese Pharmacopoeia (JP) or JPE specification. ... 

Japanese Pharmaceutical Excipients Directory,, The Japan Pharmaceutical Excipients Council, Yakuji Nippo Ltd Tokyo, 2000. 

The parent CDs in Japan are classified as natural starches that have received approval by the Ministries of Health for use in foods. Relative to pharmaceutical applications, monographs for a- and p-CD have been included in the Japanese Pharmaceutical Excipients compendium (JPE). Even though nine pharmaceutical products with CD formulations have been marketed in Japan, the use of CDs has not been extensive enough in approved formulations to receive precedent status. ... 

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