China · National Medical Products Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
2
3 requirements
Application fee
-
A drug or device in a clinical trial for a life-threatening disease without effective treatment can be given to other patients with the same condition at the trial site, after ethics review and informed consent, when medical observation suggests benefit. Devices and diagnostics are given free of charge, and their safety data can support registration. Patients who cannot join the trial but have the same serious condition.
1. Ethics review and consent; 2. Use at the trial site.
Outcome: Use at the trial institution.
Legal basis: Drug Administration Law (2019), Article 23; Regulation for the Implementation of the Drug Administration Law (2026), Article 53; Regulations on the Supervision and Administration of Medical Devices, Article 29
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, Small-quantity urgent import by hospitals, 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.