Advancing The Implementation Of ICH E17: Collaborative Efforts Driving Simultaneous Global Drug Development In China

By Chao Zhu, Lilly China Drug Development and Medical Affairs Center, and Yan Hou, Peking University

Multiregional clinical trials (MRCTs) have become a cornerstone of global drug development, enabling simultaneous evaluation of therapies while adhering to rigorous standards required for regulatory approvals across multiple regions. The ICH E17 guideline, released in 2017, provides a harmonized framework for designing and conducting MRCTs to meet the regulatory expectations of multiple regions.

China has displayed growing leadership in implementing ICH E17, driven by collaboration among regulators, academia, and industry. Through the development of the RDPAC Bluebook, stakeholders have aligned on best practices for key components of MRCTs, including data-driven pooling strategies, regional sample size allocation, and holistic benefit-risk assessments. The Bluebook offers practical guidance on identifying effect modifiers using real-world data, literature, and pharmacological modeling, and outlines structured approaches to interpreting regional variations. Challenges such as unclear pooling strategies and regional inconsistencies persist, but the integration of ICH E17 principles is strengthening trial efficiency, regulatory alignment, and global patient access.