进口三类化药注册流程 英文版

进口三类化药注册 英文版 Sponsor: providing documents according to the list, providing drug samples for Inspection Test. CRO: translating documents, preparing application documents based on SFDA requirements. CRO: Submit application documents to SFDA SFDA: check and accept if the submission meets acceptance requirement. (within 5 working days) SFDA: review submitted documents and inform of drug Inspection Test. (30 working days) Test report 1: test drug sample & evaluate standard requirementCDE: drug evaluation Test institute(85 working days) s are not (90 working days) met CRO & Sponsor: providing supplementary documents to CDE. Clinical Trial Application (Within 4 months) CDE: evaluate. 2(30 working days) SFDA : administration examination on the evaluation opinions released by CDE 30 working days qualified unqualified Clinical Trial Approved Clinical trial unapproved Clinical Trial Performance Clinical Trial Performance To be continued 1 Followed by page 1 CRO: submit application documents to SFDA together with clinical trail report and other registration documents. SFDA: check and accept if the submission meets acceptance requirement. (within 5 working days) CDE: drug evaluation (150 days) CRO & Sponsor: providing supplementary documents to CDE. (Within 4 months) CDE: evaluate. (50 working days) SFDA : administration examination on the evaluation opinions released by CDE Import Drug License Application 30 working days qualified unqualified Import Drug License Approved Import Drug License Unapproved Note: 1. Test institute: for import drug inspection test, the test institute will be NICPBP (National Institute for the Control of Pharmaceutical and Biological Products) or other test institutes of custom port. 2. When CDE evaluates the drug, usually they will issue a sheet to the applicator requiring more explanation and information, and the applicator is required to give the answers to CDE within 4 months since the sheet receiving date. 2