China · National Medical Products Administration · New drugs
Review target
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Not published
Legal time limit
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Not published
Steps
5
5 requirements
Application fee
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Designated hospitals in the Boao Lecheng pilot zone in Hainan can import drugs and devices approved abroad but not registered in China, when clinically urgent. Hainan health and drug authorities approve each use. Real-world data from this use can support a later registration in China. Drugs (not vaccines) approved abroad with no substitute registered in China, and devices approved abroad with no similar product registered in China.
1. Hospital qualification (10 days); 2. Use application by the hospital; 3. Clinical need assessment (5 days); 4. Import permit (7 days); 5. Import and use.
Outcome: Permit for one designated hospital to import and use the product for a specific medical purpose.
Legal basis: Hainan Provincial Government rules on urgently needed imported drugs and devices in the Boao Lecheng pilot zone (2023); Drug Administration Law (2019), Article 65
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).
About 22 days end to end with the official step targets. Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Decisionregulation. Provincial drug authority permit after the 5 working day health assessment. | 7 working days |
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, Hong Kong and Macao drugs and devices in the Greater Bay Area, Small-quantity urgent import by hospitals, 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 (13 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.