ABSTRACT
I. INTRODUCTION The sales of pharmaceuticals in Japan, in United States dollar terms, are sec ond only to those in the United States [1]. The significant price reductions occurring in the developing managed-care environment of the United States and the strength of the yen are likely to reduce the U.S. lead. Thus it is not surprising that U.S. pharmaceutical companies are eager to register and sell their drugs in Japan. Differences in the regulatory requirements that have been noted between these two countries have been viewed as barriers to free and fair trading in pharmaceuticals. These issues are not new, and to resolve them
the Market-Oriented, Sector-Selective (MOSS) talks [2] were set up between government officials of both countries. Although progress has been made and the talks continue, many differences remain. Among these is the fact that Ja pan insists that drugs developed elsewhere undergo, on the one hand, repeat dose-range finding and pharmacokinetic studies in Japan and, on the other, a comparative drug study. These requirements are purportedly based on the possibility of genetic variation in drug handling between Japanese and nonJapanese patients.
