China · National Medical Products Administration · Generics
Review target
200 working days
regulation
Legal time limit
-
Not published
Steps
11
12 requirements
Application fee
CN¥502,000
2015 standard
A route for generic chemical drugs that copy an originator product. The generic must match the reference product in quality and efficacy, usually shown by a bioequivalence study that is filed rather than approved. Generics may go straight to a marketing application when clinical trials are not needed. Copies of originator drugs marketed in China (category 4) or only abroad (category 3), and generics made abroad (category 5.2).
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.
The generic marketing application with clinical trial, imported is CN¥502,000 for 2015 standard.
1. Bioequivalence study filing; 2. Bioequivalence study; 3. Pre-submission meeting; 4. Marketing application; 5. Formal check and acceptance (5 days); 6. Technical review (200 days); 7. Registration inspection; 8. Registration testing (60 days); 9. Request for more data (clock stopped); 10. Approval decision (20 days); 11. Certificate issued (10 days).
Yes. It relies on approvals from European Union, Japan, United States (recognition, recognition, recognition).
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); Regulation for the Implementation of the Drug Administration Law (2026)
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 295 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 |
|---|---|
| Generic marketing application with clinical trial, importedApplication · 2015 standard | CN¥502,000 |
| Generic marketing application without clinical trial, importedApplication · 2015 standard | CN¥367,600 |
| Generic marketing application with clinical trial, made in ChinaApplication · 2015 standard | CN¥318,000 |
| Generic marketing application without clinical trial, made in ChinaApplication · 2015 standard | CN¥183,600 |
Other routes in China: Marketing authorization for an innovative drug, Improved new drug (known active substance), 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 (41 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.