Vaccine registration (Preventive biologic categories 1 to 3)
China · National Medical Products Administration · Vaccines
Full application, new active substanceHigh confidenceLast verified October 3, 2026
Review target
200 working days
regulation
Legal time limit
-
Not published
Steps
13
11 requirements
Application fee
-
What is the Vaccine registration in China?
Vaccines follow the drug registration procedure with extra rules from the Vaccine Administration Law. Trials run only at qualified top-level hospitals or provincial disease control centers. After approval, every batch needs lot release before sale or import. Innovative vaccines (category 1), improved vaccines (category 2) and vaccines already marketed in or outside China (category 3).
How long does the Vaccine registration take?
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.
What are the steps of the Vaccine registration?
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); 13. Lot release for each batch.
Outcome: Drug registration certificate valid for 5 years; batch lot release certificates. Valid for 5 years.
Legal basis: Vaccine Administration Law (2019); Drug Administration Law (2019); Provisions for Drug Registration (SAMR Order 27, 2020)
How the pathway works
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.
Steps
In order, with the official target for each step
1. Clinical trial applicationThe applicant files a clinical trial application after finishing the pharmaceutical, pharmacology and toxicology work that supports it.
2. Clinical trial review60 working daysThe Center for Drug Evaluation decides within 60 working days of acceptance. If it sends no answer in time, the trial counts as approved.
3. Clinical trialsTrials run in phases I, II and III at registered trial sites, after ethics committee approval.
4. Pre-submission meetingonly in some casesThe applicant may ask the Center for Drug Evaluation for a meeting on major issues before filing.
5. Marketing applicationThe applicant files after completing the studies, setting quality standards and validating the commercial-scale process, and is ready for inspection and testing.
6. Formal check and acceptance5 working daysThe agency decides within 5 working days to accept, ask for missing items, or reject the filing.
7. Technical review200 working days
Official time targets
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.
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 (37 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.
Vaccine registration in China: Steps, Timeline and Fees | DataPorium
The Center for Drug Evaluation reviews quality, nonclinical and clinical data. The limit is 200 working days.
8. Registration inspectionThe Center for Drug Evaluation tells the inspection center within 40 working days of acceptance to start inspection. Innovative drugs, improved new drugs and biologics get a production site inspection and a pre-approval GMP inspection.
9. Registration testing60 working daysA drug control laboratory tests samples in 60 working days, or 90 working days when it also checks the quality standard.
10. Request for more data (clock stopped)up to 80 days, clock stopped, only in some casesThe agency normally asks once for more data. The applicant has 80 working days to answer. After the answer, the review limit grows by one third.
11. Approval decision20 working daysThe agency makes the licensing decision within 20 working days after the review ends.
12. Certificate issued10 working daysThe drug registration certificate is issued and delivered within 10 working days.
13. Lot release for each batchEvery vaccine batch is reviewed and tested by a designated lot release body before sale or import.
Requirements
What the applicant must provide or meet
Clinical data
Qualified trial sitesVaccine trials are run or organized by qualified tertiary hospitals or disease control centers at provincial level or above.
Overseas applicants testing in minors(in some cases)An overseas applicant that wants to run a vaccine trial in minors in China needs at least phase I data from abroad that include the target population, except for urgently needed vaccines.
Other
Dossier format: ICH CTDThe dossier follows the ICH M4 Common Technical Document format.
Priority review for urgent and innovative vaccines(in some cases)Vaccines urgently needed for disease control and innovative vaccines receive priority review.
After approval
Lot releaseChina runs a lot release system for vaccines. Each batch is reviewed and tested before sale or import.
Post-market risk management planThe holder must have a post-market risk management plan and carry out post-market studies.
Pharmacovigilance and adverse reaction monitoringThe holder runs a pharmacovigilance system under the good pharmacovigilance practice rules and monitors adverse reactions.
Annual reportThe holder files a yearly report on production, sales, post-market studies and risk management.
Post-approval changesChanges are handled as approval, filing or annual-report changes based on their risk.
Re-registration every 5 yearsThe certificate is valid for 5 years. The holder applies for re-registration 6 months before expiry. Holders outside China apply to the national agency.
Local presence
Local legal entity for overseas companies(in some cases)An overseas applicant names a company legal person in China to handle registration. An overseas holder's named Chinese company carries the holder's duties and shares liability. Its details appear in the package insert.
