ABSTRACT
Chapter 1 describes progress in utilizing a Multi-Regional Clinical Trial (MRCT) in drug development for regulatory approval. This chapter includes (1) paradigm shift of the drug development strategy, (2) backstory of the ICH E17 expert working group, (3) key principles of the ICH E17 guideline, and (4) roles of the ICH E17 guideline in drug development. This chapter serves as a basis for the following chapters by clarifying the historical background, purpose, and key principles of the ICH E17 guideline
