ABSTRACT
Previous chapters reviewed medical technology regulation and recent government initiatives to close the “device lag” and analyzed the difficulties of bringing innovative products and medical technologies to the Japanese market. Whereas the introduction, diffusion, and use of medical technologies present challenges everywhere (Cohen and Hanf, 2004), the “device lag” and market difficulties are uniquely problematic in Japan. This chapter will address the enforcement and implementation of good clinical practice (GCP) and adverse event reporting (AER) as mandated by PAL, from a variety of perspectives—domestic and international, professional and administrative—in addition to drawing on the experience of Japanese sources, e-newsletters, and secondary literature. The aim is to demonstrate how and why the two legally mandated building blocks of PAL—in reality, borrowed from the international STED—cannot be implemented immediately, given the existing clinical conditions in Japan, and to show why the “device gap” (that is, inferior evaluation and review capabilities) will continue for some time to come. PAL has had profound implications for sponsors of clinical trials and for doctors and hospitals (Eno, 2006). 1
