Japan
JPEast Asia
Regulatory Overview
Japan is regulated by the Pharmaceuticals and Medical Devices Agency (PMDA). The country has 2 documented regulatory pathways for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
Pharmaceuticals and Medical Devices Agency (PMDA)
Regulatory Pathways (2)
Japan's early conditional approval system allowing accelerated approval of certain drugs with post-marketing commitments for patients with serious unmet medical needs.
Application Form: PMDA Early Conditional Approval Application
Legal Basis: PMD Act – Early Approval System
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: PMDA Early Approval Guidance
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.
Application Form: PMDA CU Application
Legal Basis: Pharmaceutical and Medical Device Act (PMD Act)
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: PMDA Compassionate Use Guidance
Drugs Available (93)
Japan
| ISO Code | JP |
| Region | East Asia |
| Regulatory Authority | Pharmaceuticals and Medical Devices Agency (PMDA) |
| Pathways | 2 documented |
| Drugs Available | 93 drug(s) |