Abstract
Pharmacogenomics is expected to become one of the ways by which serious drug development problems can be broken down and solved. In fact, the field of pharmaceutical development seems to be using pharmacogenomics increasingly as a means of both drug selection (via genotyping) and proper dosage determination. Before pharmacogenomics can be put to practical use, however, scientific and technical issues must first be resolved, after which social and ethical issues must be addressed. In Japan, drug developers are preparing for the introduction of pharmacogenomics into clinical trials. As they anticipate the necessary revisions, they must keep in mind not only the differences between current practice and that including pharmacogenomics, but also international standards. Therefore, developers are discussing strategies for communicating the necessary changes to academic and regulatory parties in an attempt to obtain a consensus and smoothly implement these changes. A survey of the academic and regulatory parties revealed that there were concerns about what pharmacogenomic information should be obtained, who would have access to it, and how it should be transmitted. Since industry, academia, and the regulatory body all agree that pharmacogenomics need to be implemented in Japan, deeper discussion of the science, technology, regulation, and ethics relevant to this topic should be continued both domestically and internationally.
