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Pharmaceutical industry Japan

In 1995, discussions among the United States, the European Community (EC), and Japan occurred to achieve harmonization of dmg and dmg product standards and to provide guidance to the worldwide pharmaceutical industry for acceptance of global regulatory filings. The International Committee on Harmonization (ICH) has proposed initial guidelines for the estabUshment of stabihty studies. [Pg.225]

There are thousands of commercial spectrometers in use today in materials analysis, chemistry, and ph) ics laboratories. The largest concentrations are in the US and Japan. They are used in universities, the semiconductor and computer industries, and the oil, chemical, metallurgical, and pharmaceutical industries. [Pg.283]

Sakakibara,S.and Yamanaka,T. U.S. Patent 3,749,705 July 31,1973 assigned to Yoshitomi Pharmaceutical Industries Ltd. (Japan)... [Pg.248]

M. Sumi, Japan Patent 12224 (1960), to Takeda Pharmaceutical Industries Ltd. Chem. Abstr. 55 10325a (1961). [Pg.546]

Globalization of fhe pharmaceufical industry has created the need to harmonize the recommendations for fhe developmenf of new pharmaceuticals as well as the regulatory requirements. To address this need, in 1990, experts from the pharmaceutical industry and regulators from fhe United States, Europe, and Japan joined together to establish the ICFl... [Pg.474]

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). [Pg.476]

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]. [Pg.277]

ICH home page. The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), a unique project that brings together the regulatory authorities of Europe, Japan and the USA, and experts from the pharmaceutical industry. [Pg.510]

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. [Pg.92]


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See also in sourсe #XX -- [ Pg.58 , Pg.90 , Pg.91 ]




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