抄録
Introduction of the practice based on the International Conference on Harmonization-Good Clinical Practice(ICH-GCP)has provided an international satandard for drug development, and enabled applications for approval of new drugs to the Japanese Government on the basis of clinical trial results obtained in other countries. Actually, however, clinical trials based on ICH-GCP are almost infeasible in Japan, since the ICH guidelines, particularly the GCP, are rooted in Western healthcare systems and customs. Their incongruity with the Japanese practices has already produced confusion. The present paper discusses the problems for each of the four participants in clinical trials : administration, pharmaceutical industry, doctors and medical institutions, and patients. The author elucidates the origins of the problems and proposes possible steps to solve them. These problems belong to obstacles for Japan's "internationalization"along with many others in finance, administration, research and education.
