Several factors have combined making it possible to integrate Japan into global development.
Politically, Japan has accepted its integration into the global economy across almost all industries and, without question, the pharmaceutical industry will follow.
Medically, the rapid dissemination of scientific knowledge has increased the alignment of global treatment practices making implementation of global protocols in Japan feasible.
From a regulatory perspective, since Japan adopted the ICH GCP, the MHLW/PMDA has been transformed into an agency that actively embraces global and Pan-Asian drug development, and has established an accessible and transparent system for industry to obtain clear regulatory guidance.
Finally, operationally, the clinical trials infrastructure in Japan has improved significantly making it possible for companies to conduct Japanese trials more efficiently and as part of global development.
