NMPA Compassionate Use – China
NMPA CU ApplicationDrug Administration Law 2019 Article 2360 days
Description & Eligibility
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.
Eligibility Criteria
Serious or life-threatening condition with no locally registered alternative
Legal Reference / Source
NMPA Order No. 3 (2019)
Countries Using This Pathway (1)
NMPA Compassionate Use – China
| Approval Form | NMPA CU Application |
| Timeline | 60 days |
| Legal Status | Drug Administration Law 2019 Article 23 |
| Source Ref. | NMPA Order No. 3 (2019) |
| Countries | 1 countries |
Compliance Check
Legal Review3/11/2026
Global ValidityVerified