Japanese Pharmaceutical Manufacturers

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. 

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). 

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... 

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

Proposals for revision of the JP monographs or test methods can be submitted through the JP secretariat in the Pharmaceutical and Medical Safety Bureau by any concerned individual or organization. The proposed monograph, either for a new entry or for a revision, is then drafted by a panel member or an industry professional. New or revised test methods are handled in a similar manner. To accomplish this, panels are assisted by the Japanese Pharmaceutical Manufacturers Associations of Tokyo and of Osaka, the Japan Pharmaceutical Excipients Council, the Crude Drugs Association of Tokyo, the Federation of Crude Drugs Association of Japan, and the Japanese Society of Hospital Pharmacists. 

In 1991, the Commission of European Communities, the FDA, the Japanese Ministry of Heath and Welfare, the International Federation of Pharmaceutical Manufacturers Associations, the European Federation of Pharmaceutical Manufacturers Associations, the U.S. Pharmaceutical Manufacturers Association and the Japanese Pharmaceutical Manufacturers Association organized the first International Conference on Harmonization (ICH). The goal of the conference was to begin to harmonize requirements for regulatory submissions in the United States, Europe and Japan in the areas of quality, safety, and efficacy. One of the quality topics was stability testing. 

Data Book, Japanese Pharmaceutical Manufacturers Association. 

Japanese Pharmaceutical Manufacturers Association, Center For Pharmaceutical Publications. 2006. Data Book. 

Japan Ministry of Health and Welfare (MHW) and the Japanese Pharmaceutical Manufacturers Association (JPMA)... 

The principles of actinometry are well established, but there is no well-established actinometric system sensitive only to UV radiation (Kuhn et al., 1989 Piechocki and Wolters, 1993). Quinine was originally proposed by the Japanese National Institute of Health Sciences and the Japanese Pharmaceutical Manufacturer s Association (Yoshioka et al., 1994). The results of the work of the FDA and U.S. laboratories have confirmed its suitability (Drew et al., 1998). At the recommended concentration (2%), the quinine solution has an absorbance of >2 from 320 to 367 nm, so the UV irradiance over this range will be determined using this system. Quinine usually contains a number of alkaloid impurities, principally dihydroquinine. However, the level of the latter does not affect its performance as a UV actinometer. 

The topic to develop harmonized guidelines on the practice of safety pharmacology was proposed to the ICH—Steering Committee by the Japanese delegates (Japanese Pharmaceutical Manufacturers Association (JPMA) and Ministry of Health and Welfare [MHW now referred to as the Ministry of Health, Labour and Welfare (MHLW)], in 1997, and adopted as the Topic S7 in 1998. The membership of the ICH S7 EWG and a chronicle of the timelines and milestones are presented in Tables 1 and 2, respectively. 

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