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1. Applicant completes drug registration form; production application dossier and application for inspection of production site
FDA conducts formal examination if accepted, within 5 days ,on-site
inspection of production site and drug research data, and takes sample
drugs from 3 consecutive batches
CDE arranges for pharmaceutical, medical and other technical staff to examine the verification
recommendation and the application provide supplemental information if necessary
SFDA makes approval decision based on the general recommendation
Issue drug approval Number
(within 10 days)
Clinical Trial Approval
(within 10 days)
The drug control Institute tests the sample
product and sends the sample test report to
CDE, PFDA and applicant (30 days)
Applicant submits clinical trial report to CDE
CDE conducts technical examination of clinical trial report
SFDA makes approval decisions based on the technical examination recommendations(30days)
Issue drug approval Number (within 10 days) Notification of approval opinion (within 10 days)
After examination of the application dossier, PFDA submits application dossier, its examination
recommendation
Generics drug approval and approval in China
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