Abstract
Japanese GLP were developed and published some time after their counterparts in the US. It is, therefore, interesting to see in which way the Japanese authorities decided to make changes in the light of experience in the U.S. Facility petition for confirmation is an example of a different approach. With this procedure, whereby information in great detail must be submitted, the Japanese Ministry of Agriculture, Forestry and Fisheries (MAFF) has taken on an ongoing task of some magnitude. For now Japanese sponsors and contract laboratories, there are many possibilities for misunderstandings. These include language, culture, differing corporate/organization structures, differing job titles. We must realize, however, that it is also difficult for the Japanese authorities, who are faced with the same problems in reverse. It appears that bilateral arrangements are the answer, but these are slow to materialize.
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