China · National Medical Products Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
4
2 requirements
Application fee
-
During clinical trials, an innovative or improved new drug for a serious or life-threatening disease can enter the breakthrough therapy procedure if there is no effective treatment or it shows a clear advantage. It gives more meetings with the Center for Drug Evaluation and advice on staged data. Products in it can later ask for priority review. During clinical trials, for drugs against diseases that seriously threaten life or quality of life.
1. Application to the Center for Drug Evaluation; 2. Assessment and public notice; 3. Meetings and staged advice; 4. End of the procedure.
Outcome: Inclusion in the procedure after a public notice period.
Legal basis: Provisions for Drug Registration (SAMR Order 27, 2020), Articles 59 to 62; Regulation for the Implementation of the Drug Administration Law (2026), Article 15
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, Vaccine registration, 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, Expanded access at clinical trial sites. See all routes on the China page 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 (8 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.