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In Japan, the Re-Examination System is a unique regulatory framework that evaluates the safety and efficacy of a drug after it has been approved and marketed.

Mandated under the Pharmaceuticals and Medical Devices Act (PMD Act) and overseen by the PMDA, this system ensures that products continue to meet regulatory standards based on real-world data collected during the post-marketing phase.

How Does the Re-Examination System Work?

After approval, drugs are assigned a re-examination period typically ranging from 4 to 10 years, depending on the product type and level of innovation.

During this period, companies must:

  • Conduct post-marketing surveillance (PMS)
  • Collect and analyze real-world safety and efficacy data
  • Submit periodic reports to PMDA
  • Maintain compliance with GPSP and GVP requirements

What Does It Cover?

The system evaluates:

  • Long-term safety profile
  • Effectiveness in real-world use
  • Risk-benefit balance
  • Compliance with approved labeling

In simple terms:
Approval is conditional re-examination confirms long-term viability.

Why It Matters

Japan’s re-examination system directly impacts:

  • Product lifecycle strategy
  • Market exclusivity period
  • Post-marketing obligations
  • Regulatory risk and compliance

Failure to meet requirements can lead to:

  • Changes in approval conditions
  • Label modifications
  • In extreme cases, withdrawal of approval

The Bottom Line

Japan’s re-examination system makes post-approval strategy just as important as pre-approval success.Companies must proactively plan for PMS, RMP, and lifecycle compliance to ensure long-term market sustainability.