China · National Medical Products Administration · New drugs
Review target
130 working days
regulation
Legal time limit
70 working days
regulation
Steps
5
6 requirements
Application fee
-
Drugs with clear clinical value can get priority review at the marketing application. The review limit is 130 working days instead of 200, and 70 working days for urgently needed rare disease drugs already marketed abroad but not in China. Inspection, testing and name approval are scheduled first. At the marketing application, after a meeting with the Center for Drug Evaluation.
The official review target is 130 working days (regulation). The legal time limit is 70 working days. Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Meeting with the Center for Drug Evaluation; 2. Marketing application with priority request; 3. Priority review (130 days); 4. Request for more data (clock stopped); 5. Approval decision (20 days).
Outcome: Faster review within the priority time limits.
Legal basis: Drug Administration Law (2019), Article 96; Provisions for Drug Registration (SAMR Order 27, 2020), Articles 68 to 71
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 150 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
| Legal time limitregulation. Urgently needed rare disease drugs marketed abroad but not in China. | 70 working days |
| Review targetregulation. These are official maximum working-day limits in the rules, not actual review times. 70 working days for urgently needed rare disease drugs already marketed abroad. | 130 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, Vaccine registration, Breakthrough therapy procedure, Conditional 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 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 (15 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.