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Objectives and achievements of regulations in Japan

  • C. N. Roberts
Chapter
Part of the CMR Workshop Series book series (CMRWS)

Abstract

  1. 1.

    Twenty essential functions of medicines regulation are proposed. In most of these the Japanese Ministry of Health and Welfare has been successful to some degree.

     
  2. 2.

    The last decade has seen a proliferation of written material and translations, in English, relating to Japanese drag regulations. Thus commercially important information about Japan is now available.

     
  3. 3.

    Within Japanese regulations is a responsibility for research and development. Recent initiatives, with appropriate funding, have been taken by the government.

     
  4. 4.

    At present adverse drug reaction reports are obtained from nominated hospitals, clinics and pharmacies, but the reporting rate is low. Therefore a review of other international systems is underway.

     
  5. 5.

    Two extensive re-evaluation programmes of older products have been conducted in Japan, and in future all active ingredients will be reviewed every five years, following approval.

     

Keywords

National Health Insurance Medicine Regulation Drug Regulation Good Laboratory Practice Marketing Authorization Application 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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References

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    Worden A N and Roberts C N (1972). Experimental and Clinical Evaluations of Drugs and Drug Safety, Proceedings Japan — British Medical Symposium, Japan Medical Association, Tokyo 128–146Google Scholar
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Copyright information

© Kluwer Academic Publishers 1989

Authors and Affiliations

  • C. N. Roberts

There are no affiliations available

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