ABSTRACT
The idea and function of conducting bridging studies after a medical product has been approved in one or more of the three major International Conference on Harmonisation (ICH) regions-the United States, the European Union, and Japan-as described in ICH (1998a) E5 guidance are discussed in other chapters of this book. Moving forward toward a simultaneous drug development, the pharmaceutical industry has globalized its research and development (R&D) to provide quality medical products around the world to meet patients’ needs in various regions and countries. One of the key R&D globalization components is to conduct global clinical trials-also called multiregional clinical trials (MRCTs)—in which patients from multiple regions, countries, and medical institutions around the world are accrued and studied simultaneously in accordance with a common clinical trial protocol.
