China · National Medical Products Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
5
5 requirements
Application fee
-
A drug can be approved on early clinical data that show efficacy and predict clinical value when it treats a life-threatening disease without effective treatment or meets an urgent public health need. Some urgently needed vaccines also qualify. The certificate lists its validity and the studies to finish after approval. During clinical trials, before the marketing application, after agreeing the conditions with the Center for Drug Evaluation.
1. Agree conditions with the Center for Drug Evaluation; 2. Marketing application; 3. Review; 4. Conditional approval; 5. Confirmatory studies.
Outcome: Registration certificate with conditions, a validity period and post-approval study deadlines.
Legal basis: Drug Administration Law (2019), Articles 26 and 78; Vaccine Administration Law (2019), Article 20; Provisions for Drug Registration (SAMR Order 27, 2020), Articles 63 to 67
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, Breakthrough therapy procedure, 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 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 (10 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.