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Japanese clinical data comparability refers to the process of showing that the safety and effectiveness of a drug — proven in non-Japanese patients (often Caucasian) — is also true for Japanese patients.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) requires this because ethnic differences — such as genetics, body composition, diet, or metabolism — can affect how a drug works. Data from Western clinical trials may not always apply directly to Japanese patients.

To confirm comparability, companies may:

  • Conduct bridging studies in Japanese patients
  • Include Japanese participants in global multi-regional clinical trials (MRCTs)
  • Perform PK/PD studies to check absorption and drug processing

This ensures the treatment is safe and effective for Japanese patients before approval.

Why it matters: Without demonstrating comparability, PMDA approval can be delayed, leading to extra studies and higher costs.

How Freyr Solutions helps:

Freyr’s Japan-based experts guide companies in:

  • Reviewing existing foreign data for gaps
  • Designing and managing local Japanese studies
  • Preparing PMDA-compliant documentation
  • Engaging with the PMDA early to avoid roadblocks

f you’re bringing your product to Japan, let Freyr Solutions help you bridge the gap with expert clinical data comparability strategies. Contact us today.