Objectives and achievements of regulations in Japan
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.
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.
Within Japanese regulations is a responsibility for research and development. Recent initiatives, with appropriate funding, have been taken by the government.
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.
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.
KeywordsNational Health Insurance Medicine Regulation Drug Regulation Good Laboratory Practice Marketing Authorization Application
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