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Internationalization of the Japanese Pharmaceutical Regulations and Environment

Published online by Cambridge University Press:  10 March 2009

Klaus Kran
Klaus Kran
Affiliation:
Searle Yakuhin K.K., Japan
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Extract

The intensity with which the United States and the European Community (EC) are reviewing their trade difficulties with Japan makes examination of the Japanese pharmaceutical regulatory environment particularly appropriate at this time. One of the four topics identified for focused discussion between the U.S. and Japanese governments in last year's Market Oriented Sector Selective (MOSS) talks was pharmaceuticals, a $13 billion industry (at 1985 exchange rates), in which Japan is the world's second largest market for pharmaceuticals.

Type
Special Section: The Evaluation of Drugs: An International Perspective
Information
International Journal of Technology Assessment in Health Care , Volume 2 , Issue 4 , October 1986 , pp. 691 - 699
Copyright
Copyright © Cambridge University Press 1986

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References

REFERENCES

1.Requirements for the registration of drugs in Japan. 2nd ed. Yakuji Nippo, Ltd., 1986.Google Scholar
2.U.S.-Japan Study Group, Progress report 1984. Washington, DC: U.S. Government Printing Office, 1984.Google Scholar
3.U.S. Department of the Treasury, Report on medical equipment and pharmaceutical Market-Oriented, Sector-Selective (MOSS) Discussions. Washington, DC: U.S. Government Printing Office, 1986.Google Scholar