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Cost & Time for Drug China CFDA Registration (Clinical Trials Permission (CTP) Phase)

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

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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,)

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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

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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 documentsAnalyse its resulting risk of registration. 

4

CFDA Application Dossiers Draft, Edit, Compile , Pre-review and Official Submit

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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 )

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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 ),

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9- 12 Months

1Follow up drug technical evaluation in CDE, communicate with reviewing technological expert, and solve problems met during review at any time. 2Promptly submit supplemental dossiers required by CDE if technical dossiers need to be corrected.

7

Clinical Trials Permission 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 clinical trial Permission Approval.

 

Total:

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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

2The 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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