Imported Drug
CFDA Registration Charge and timetable
Phase A.
Clinical
Trials Permission (CTP) Phase:
|
Step |
ITEM |
COST
(USD) |
TIME |
Work
content |
|
1 |
China
CFDA Registration consultant & Legal responsibility Agency |
contact us |
5 years |
On
behalf of the applicant, communicate with the CFDA and relevant
government departments, in the 5 years certificate validity period |
|
2 |
Original Legal &Technical documents prepare and Translation
(English-Chinese,) |
contact us |
1-2
Months
|
1.Explanation the CFDA registration procedure and regulation for
Applicant in detail
2.
Provide the list of application dossiers need to be submitted, including
technical & legal documents, and describe the requirements of each
documents in detail.
3.
Translate all Original Legal &Technical documents provided by Applicant,
|
|
3 |
Original Legal & Technical documents Pre-review |
contact us |
1-2
Months
|
1.
Pre-review all Original Legal &Technical documents, and instruct
Applicant to revise the gaps where are not met. Requirements of CFDA
2. Find
out defects factors in the original Legal &Technical documents，Analyse
its resulting risk of registration. |
|
4 |
CFDA
Application Dossiers Draft, Edit, Compile , Pre-review and Official
Submit |
contact us |
3 - 5
Months |
1.
Draft and Compile all of CFDA application Dossiers (32
documents), base on the Original Legal & Technical documents provided by
Applicant.
2. Find
relevant expert for pre-evaluation when necessary, and ensure the
completeness of dossiers.
3.
Legal Document Chinese version Notarization: LOA, FSC, GMP,etc |
|
5 |
NICPBP
Drug Tests conduct & Follow up
(Time controlled by
NICPBP ) |
contact us |
4- 6
Months
|
1.
Prepare technical dossiers required for NICPBP tests.
2.
Arrange NICPBP test and follow up the test procedure,
3.
Communicate with NICPBP relevant officers to promote pass of
testing. |
|
6 |
CDE
Technical Evaluation & Follow up
( Time is controlled by
CDE
), |
contact us |
9- 12
Months |
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. |
|
7 |
Clinical Trials Permission CFDA Approval & Follow up |
contact us |
1-2
Months
(Time
controlled by
CFDA
)
|
Communicate with relevant officers, promote rapid and successful pass of
clinical trial Permission Approval. |
|
|
Total: |
contact us |
2-3
years |
Include the CFDA official charge & test cost. |
Notes:
1．
Abbreviations define: CFDA: China Food & Drug Administration ;
CDE:
Center forDrug 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.
|
