China · National Medical Products Administration · New drugs
Review target
-
Not published
Legal time limit
-
Not published
Steps
3
3 requirements
Application fee
-
When a public health emergency threatens or happens, the agency can use special approval for drugs needed to respond. Acceptance, review, inspection and testing run faster and in parallel. Use can be limited to a set period and scope. Separately, vaccines can be used in an emergency within a set scope and period after expert review. Drugs and vaccines needed for a public health emergency.
1. Agency decides to use special approval; 2. Parallel acceptance, review, inspection and testing; 3. Approval, possibly limited.
Outcome: Approval that may be limited in time and scope.
Legal basis: Provisions for Drug Registration (SAMR Order 27, 2020), Articles 72 to 75; Vaccine Administration Law (2019), Article 20
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, Conditional approval, Priority review and approval, 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 (5 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.