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ICH E17-GL is an international guideline on how to design multi-regional clinical trials (MRCTs) — studies that enroll patients from different regions in one global trial.

Its goal is to create trial designs that work for multiple countries, so companies can submit one strong data package to regulators worldwide.

Key principles include:

  • Early planning with all regions in mind
  • Enough participants from each region (including Japan)
  • Considering ethnic factors in drug response
  • Consistent trial conduct across countries

For Japan, the PMDA expects meaningful inclusion of Japanese patients in MRCTs, so results can be applied locally without extra bridging studies.

Why it matters: Following ICH E17 saves time, avoids duplicated trials, and speeds up market entry.

How Freyr Solutions helps:

Our Japan-based team works with global sponsors to:

  • Plan MRCTs aligned with ICH E17
  • Ensure correct Japanese sample sizes
  • Manage PMDA communications and requirements
  • Deliver globally valid, locally accepted data

Design your MRCTs right the first time. Talk to Freyr Solutions for ICH E17 and PMDA-aligned trial strategies.