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2 min read
In today’s global pharmaceutical landscape, multi-regional clinical trials (MRCTs) have become a cornerstone of efficient drug development. By enrolling patients across multiple geographic regions in a single trial, sponsors can accelerate development timelines, reduce redundancy, and meet regulatory requirements in multiple markets simultaneously.
The ICH E17 guideline, “General Principles for Planning and Design of Multi-Regional Clinical Trials,” provides a harmonized framework for designing MRCTs that generate robust, regionally relevant evidence for regulatory submissions. For companies aiming to include Japan in their MRCT strategy, understanding and applying ICH E17-GL is critical — both for scientific validity and for meeting PMDA expectations.
Purpose of ICH E17-GL
ICH E17-GL was developed to:
- Harmonize MRCT planning across ICH member regions.
- Enable simultaneous drug development that satisfies multiple regulatory authorities.
- Support extrapolation of results across regions without unnecessary duplication of trials.
- Ensure diverse population representation, addressing potential ethnic or regional differences in drug response.
Core Principles for MRCT Planning
The guideline outlines several key elements for successful MRCT design:
- Early and Inclusive Planning – Regional input should be sought early to align on trial objectives, endpoints, and operational considerations.
- Appropriate Sample Size Allocation – Ensure enough patients are enrolled in each region, including Japan, to support bridging and comparability assessments.
- Consideration of Ethnic Factors – Integrate ICH E5 guidance on intrinsic (genetic, physiological) and extrinsic (diet, healthcare systems) factors affecting drug response.
- Consistent Study Conduct – Harmonize protocols, procedures, and data collection across sites to ensure scientific validity.
- Regulatory Engagement – Maintain dialogue with authorities like the PMDA throughout trial planning to avoid surprises at submission.
ICH E17 and Japan’s PMDA
Japan’s PMDA actively encourages inclusion of Japanese patients in MRCTs to avoid the need for separate bridging studies. However, the PMDA expects careful sample size planning, robust statistical justification for pooling data, and a clear demonstration of data consistency across regions.
Sponsors that fail to meet these expectations risk delayed approvals or requests for additional local trials.
How Freyr Solutions Supports MRCT Success
At Freyr Solutions, we help global sponsors design MRCTs that meet ICH E17-GL principles while aligning with Japan-specific regulatory needs. Our Japan-based bilingual experts work closely with global teams to:
- Provide early regulatory intelligence from the PMDA.
- Conduct feasibility assessments for Japanese patient recruitment.
- Optimize sample size allocation for Japanese inclusion.
- Support end-to-end MRCT documentation and submissions.
By combining global regulatory expertise with deep local insight, Freyr ensures MRCTs generate data that is both scientifically robust and regionally compliant — accelerating approvals and avoiding costly delays.
Conclusion
ICH E17-GL offers a powerful framework for designing MRCTs that serve multiple markets efficiently. For companies targeting Japan, incorporating PMDA requirements from the outset is essential. With Freyr Solutions as your strategic partner, you gain access to local Japanese expertise, global experience, and a proven methodology for turning ICH E17 principles into regulatory success.
Freyr Solutions — bridging global trial design with local regulatory excellence in Japan.
