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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

Step

ITEM

COST(USD)

TIME

Work content

3

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

4

CDE Technical Evaluation & Follow up

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6- 10

Months

( 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.

5

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.

 

Total:

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 10-14 months

 

Notes:

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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