Application Dossiers Draft, Edit, Compile , Pre-review and Official
Compile clinical trial report and relevant clinical study dossiers
according to the results of clinical trial
Modify quality standards of product and other application dossiers to be
modified according to the results of NICPBP examination.
Compile 32 application dossiers required for CFDA IDL.
Formal submission to CFDA
Technical Evaluation & Follow up
( Time is
controlled by CDE ),
up drug technical evaluation in CDE, communicate with reviewing
technological expert, and solve problems met during review at any time.
submit supplemental dossiers required by CDE if technical
dossiers need to be corrected.
Drug Licence CFDA Approval & Follow up
controlled by CFDA
Communicate with relevant officers, promote rapid and successful pass of
Import Drug Licence CFDA Approval.
Abbreviations define: CFDA: China Food & Drug Administration ; CDE:
Center for Drug Evaluation , NICPBP :National
Institute for the Control of Pharmaceutical & Biological Products
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.