China
CNEast Asia
Regulatory Overview
China is regulated by the NMPA (National Medical Products Administration). The country has 1 documented regulatory pathway for accessing unapproved or unlicensed medicines, covering named patient programs, compassionate use schemes, and special access arrangements.
Regulatory Authority
NMPA (National Medical Products Administration)
Regulatory Pathways (1)
NMPA Compassionate Use – China 60 days
China's NMPA allows conditional approval and compassionate use of drugs under the 2019 Drug Administration Law for patients with serious or life-threatening conditions who have no other options.
Application Form: NMPA CU Application
Legal Basis: Drug Administration Law 2019 Article 23
Eligibility: Serious or life-threatening condition with no locally registered alternative
Reference: NMPA Order No. 3 (2019)
Drugs Available (3)
| Drug | Access Route | Status | Lead Time |
|---|---|---|---|
| mycophenolate mofetil | — | — | — |
| phacoemulsification surgery | — | — | — |
| Cerebrolysin | — | — | — |
China
| ISO Code | CN |
| Region | East Asia |
| Regulatory Authority | NMPA (National Medical Products Administration) |
| Pathways | 1 documented |
| Drugs Available | 3 drug(s) |