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Cost & Time for Drug China CFDA Register(Import Drug Licence (IDL) approval Phase)



Phase C.         Import Drug Licence (IDL) approval Phase





Work content


FDA Application Dossiers Draft, Edit, Compile , Pre-review and Official Submitit

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1-3 months

1.    Compile clinical trial report and relevant clinical study dossiers according to the results of clinical trial

2.    Modify quality standards of product and other application dossiers to be modified according to the results of NICPBP examination.

3. Compile 32 application dossiers required for CFDA IDL.

4. Formal submission to CFDA


CDE Technical Evaluation & Follow up

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6- 10


( Time is controlled by CDE ),

1£?Follow up drug technical evaluation in CDE, communicate with reviewing technological expert, and solve problems met during review at any time.

2£?Promptly submit supplemental dossiers required by CDE if technical dossiers need to be corrected.


Import Drug Licence CFDA Approval & Follow up

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1-2 Months  (Time controlled by  CFDA )

Communicate with relevant officers, promote rapid and successful pass of Import Drug Licence CFDA Approval.



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 10-14 months



1£? Abbreviations define: CFDA: China Food & Drug Administration ; CDE: Center for Drug Evaluation , NICPBP :National Institute for the Control of Pharmaceutical & Biological Products

2£?The time of CFDA review , NICPBP products testing, CDE technical Evaluation etc, can not be controlled by the agent, so,any time be postponed cause by such step, will not be included in the time commitment appraisal of the agent service.



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Important Note
Due to the reorganization of the Chinese government in 2018,
CFDA (China Food and Drug Administration) was renamed to NMPA (National Medical Product Administration), and its food supervision function has been transferred to SAMR (State Administration for Market Regulation of China);
GACC (General Administration of Quality Supervision, Inspection and Quarantine of China) was abolished, and its import and export trade supervision function has been transferred to GACC (General Administration of Customs of China),
Therefore, all
CFDA and SFDA on this website default to NMPA, GACC defaults to GACC; 
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