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 |
contact us |
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 |
contact us |
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 |
contact us |
1-2
Months
(Time
controlled by
CFDA
)
|
Communicate with relevant officers, promote rapid and successful pass of
Import Drug Licence CFDA Approval. |
|
|
Total: |
contact us |
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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