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Pharma Knowledge Base

Japan Compassionate Use (Dojo) – PMDA

PMDA CU ApplicationPharmaceutical and Medical Device Act (PMD Act)60 days

Contents

  1. 1. Description & Eligibility
  2. 2. Countries Using This Pathway

Description & Eligibility

PMDA's compassionate use (Dojo) system allows access to promising investigational drugs for patients who have exhausted other treatments and cannot wait for full approval.

Eligibility Criteria

Serious or life-threatening condition with no locally registered alternative

Legal Reference / Source

PMDA Compassionate Use Guidance

Countries Using This Pathway (1)

JP
Japan
JP
Japan Compassionate Use (Dojo) – PMDA
Approval FormPMDA CU Application
Timeline60 days
Legal StatusPharmaceutical and Medical Device Act (PMD Act)
Source Ref.PMDA Compassionate Use Guidance
Countries1 countries
Compliance Check
Legal Review3/11/2026
Global ValidityVerified