China · National Medical Products Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
-
A hospital with an urgent clinical need can import a small quantity of an unregistered drug, or of a class II or III device, with approval from the national agency or a province authorized by the State Council. The product is used only in the named hospital for a specific purpose. Urgent clinical need for a product not registered in China.
1. Hospital application; 2. Review; 3. Use in the designated hospital.
Outcome: Permission to import a small quantity for use in a designated hospital.
Legal basis: Drug Administration Law (2019), Article 65; Regulation for the Implementation of the Drug Administration Law (2026), Article 47; Regulations on the Supervision and Administration of Medical Devices, Article 57
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
Official step durations
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| No time targets published. |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in China: Marketing authorization for an innovative drug, Improved new drug (known active substance), Generic chemical drug, Nonprescription (OTC) drug application, Breakthrough therapy procedure, Conditional approval, Priority review and approval, Special approval for public health emergencies, 30 working day review channel for innovative drug clinical trials, Urgent import in the Hainan Boao Lecheng pilot zone, Hong Kong and Macao drugs and devices in the Greater Bay Area, Expanded access at clinical trial sites, Class I device and IVD filing, . See all routes on the or explore them in the .
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.