Future perspectives of regulations in Japan
The Pharmaceutical Affairs Bureau of the Ministry of Health and Welfare (MHW) in Japan is responsible for the drug review system. The approach to new drug evaluation includes a policy of transparency in its everyday work, adherence to a standard processing period of 18 months and plans for a new consultation procedure for drug manufacturers.
A proposal for Good Clinical Practice (GCP) was issued in December 1985, encompassing the whole range of medical practice relating to investigational trials on drugs. Comments have been received and the GCP may be finalized by the end of 1988.
A proposal from an experts’ group, founded in 1986 to consider international harmonization of toxicity test guidelines, is being considered, and includes such recommendations as the abolition of the requirement for LD50 tests. Foreign pre-clinical data are acceptable if the data meet the requirements or are equivalent from a scientific point of view, to the Japanese guidelines.
The pace has been increased, at which new guidelines for clinical trials are issued by MHW; a further ten or more are planned for the next two years. Foreign clinical data are aceptable, although due to potential effects of racial and environmental factors, some trials have to be conducted in Japan.
MHW are striving for further international harmonization of guidelines to avoid unnecessary repetition of research.
KeywordsGood Clinical Practice Japanese Guideline Central Nervous System Drug Clinical Trial Protocol Biotechnology Product
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