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