ABSTRACT
Chapter 7 describes regulatory progress in drug development using multi-regional clinical trial (MRCT) data in Japan in the last decades. Japan has utilized MRCT data even before the issue of the ICH E17 guideline, and such experiences have been reflected in the key principles of the ICH E17 guideline and current practice in Japan. The chapter discusses the challenges and impacts of the ICH E17 guideline implementation in Japan, including the past experiences in reviewing MRCT data for drug approval.
