Japan Pharmaceutical Manufacturers Association

There are six parties directly involved in ICH as well as observers and the International Federation of Pharmaceufical Manufacturers Association (IFPMA see Table 25.1). The six parties are the founder members of ICH, and fhey represenf fhe regulatory bodies and the research-based industry in the European Union (EU), Japan, and the United States in the EU, the European Federation of Pharmaceufical Indusfries and Associations (EFPIA) and the Ministry of Healfh, Labour, and Welfare (MHLW) in Japan, the Japan Pharmaceutical Manufacturers Association (JPMA) and in the United States, the FDA and the Pharmaceutical Researchers and Manufacturers of America (PhRMA). 

Japan Pharmaceutical Manufacturers Association. New Drug Development and Approval Process, http //www.jpma.or.jp/12english/guide industry/new drug/new drug.html [accessed August 8, 2002]. 

Founded in 1990, the International Conference on Harmonization (ICH) is comprised of the pharmacopeial manufacturers associations in Europe (EFPIA), Japan (JPMA), the United States (PMA), and the drug regulatory agencies in Europe (EEC), Japan (MHW), and the United States (FDA), with the International Federation of Pharmaceutical Manufacturers Association (IFPMA) serving as secretariat. Pharmacopeias are not members of the ICH, where membership is reserved for three PMAs and three regulatory agencies. Invited observers include Canada, WHO, and the European Free Trade Association (EFTA). 

Pharmaceutical Administration and Regulation in Japan, March 2004, Japan Pharmaceutical Manufacturers Association. Available at http / /www.jpma. or.jp / 12enghsh / parj / index.html. 

Japan Pharmaceutical Manufacturers Association (JPMA) The key objective of JPMA is the development of a competitive pharmaceutical industry with a greater awareness and understanding of international issues. Over ninety companies are members, including all the major research-based pharmaceutical manufacturers in Japan. ICH work is coordinated through specialized committees of industry experts. JPMA promotes and encourages the adoption of international standards by its member companies. 

One of the key elements for its success is most probably the composition of the organization. It was founded in 1990 as a joint regulatory/industry initiative. The six cosponsors are the EC and the EFPIA (European Federation of Pharmaceutical Industries Association) for the EU, the MHLW and JPMA (Japan Pharmaceutical Manufacturers Association) for Japan, and the U.S. FDA and PhRMA (Pharmaceutical Research and Manufacturers of America) for the United States. 

The Japanese Ministry of Health, Labour and Welfare, and the Japan Pharmaceutical Manufacturers Association. 

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. 

Japan Pharmaceutical Manufacturers Association (JPMA) JPMA represents 90 member companies. Membership includes all the major research-based pharmaceutical manufacturers in Japan. 

The ICH Committee consists of the European Commission of the European Union (EU), the European Federation of Pharmaceutical Industries and Associations (EFPIA), the Ministry of Health and Welfare, Japan (MHW), the Japan Pharmaceutical Manufacturers Association (JPMA), the U.S. 

Japan Pharmaceutical Manufacturers Association (JPMA) established the self-regulatory code Code of Practices for Promotion of Ethical Drugs in 1993. 

Japan Japan Pharmaceutical Manufacturers Association Torii Nihonbashi Building 3-4-1 Nihonbashi-Honcho Chuo-Ku Tokyo 103-0023 Japan Tel 00 81 03 3241 0326 Fax 00 81 03 3242 1767 ... 

Japan Pharmaceutical Manufacturers Association. Promotion Code for Prescription Drugs, April 2004 (www.jpma.or.jp/english/isuues/index.html). 

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

International Conference on Harmonisation (ICH) The ICH was formed to provide an opportunity for tripartite harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH is sponsored by the European Commission, the European Federation of Pharmaceutical Industry Associations, the Japanese Ministry of Health and Welfare, the Japanese Pharmaceutical Manufacturers Association, the U.S. Food and Drug Administration, and the Pharmaceutical Research and Manufacturers of America. The objective of the ICH is to harmonize the technical requirements for the registration of pharmaceutical products in the European Union, Japan, and the United States. 

The Foundation of Pharmaceutical Manufacturers Association of Japan The Nagai Foundation... 

Japan Pharmaceutical Manufacturers Association, Data Book 1990 (Tokyo, Japan Japan PharmaceuticalManufacturers Association, 1990)... 

Reich, M. R., Policy Challenges Facing the Pharmaceutical Industry in Japan, paper presented at the 1991 Pharmaceutical Manufacturers Association International Section Annual Meeting, Scottsdale, AZ, April 23-26, 1991. 

Japan Pharmaceutical Manufacturers Association marketing authorization apphcation... 

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