Future Directions of Global Drug Developments on the basis of Japanese Regulatory Experience to Accept Foreign Clinical Data

摘要

Foreign clinical data have been accepted as a part of clinical data package of Japanese NDA since ICH E5 guideline was implemented in Japan in 1998. A drug development has been recently more globalized and multi-regional clinical trials (MRCTs) have been conducted in both ICH and non-ICH regions. Based on the experiences of the review of the ICH-E5 bridging study (ICH E5), it has been recognized that a drug sometimes behaves differently among populations and dose-finding study is critical and important step in drug development.