Although the International Conference on Harmonization (ICH)-based Good Clinical Practice (GCP) regulation was introduced in Japan in 1997–1998, it is not easy to adopt the new standard because of unique medical and social practices in Japan. Difficulty in obtaining informed consent, a shortage of clinical research coordinators, and a lack of social awareness are the major obstacles. To retain clinical research within the country, substantial measures should be taken by both regulators and sponsors.
