China · National Medical Products Administration · New drugs
Review target
200 working days
regulation
Legal time limit
-
Not published
Steps
12
10 requirements
Application fee
-
A route for drugs that improve a known active substance, for example a new salt, dosage form, route, combination or indication, and that show a clear clinical advantage. The procedure and time limits are the same as for innovative drugs. New dosage forms, new routes, new combinations, new indications or other changes to a known active substance with a clear clinical advantage. A new indication for a marketed drug that needs trials starts with a new clinical trial application.
The official review target is 200 working days (regulation). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
1. Clinical trial application; 2. Clinical trial review (60 days); 3. Clinical trials; 4. Pre-submission meeting; 5. Marketing application; 6. Formal check and acceptance (5 days); 7. Technical review (200 days); 8. Registration inspection; 9. Registration testing (60 days); 10. Request for more data (clock stopped); 11. Approval decision (20 days); 12. Certificate issued (10 days).
Outcome: Drug registration certificate valid for 5 years. Valid for 5 years.
Legal basis: Drug Administration Law (2019); Provisions for Drug Registration (SAMR Order 27, 2020); chemical and biologic registration category notices (2020)
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 355 days end to end with the official step targets, of which up to 80 days are clock stops (time the applicant uses to answer). 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
| Validationregulation. Time to accept or reject the filing. | 5 working days |
| Decisionregulation. Decision after the review ends. | 20 working days |
| Longest clock stopregulation. Time the applicant has to send supplementary data. | 80 working days |
| Review targetregulation. These are official maximum working-day limits in the rules, not actual review times. Applicant answer time is not counted. | 200 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| No fees published. |
Other routes in China: Marketing authorization for an innovative drug, 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, Expanded access at clinical trial sites. See all routes on the China page or explore them in the Regulatory section.
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 (35 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.