Home    CFDA Registration   AQSIQ Register   CIQ Inspection   CNCA Registration   NHFPC(MOH) Register   MOA Register      Contact Us


Cost & Time for Drug China CFDA Register(Import Drug Licence (IDL) approval Phase)

 

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 ),

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.

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

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.

 

        Similar topics:


 

Similar Topics
 Top Articles
  • The procedure for Import Drug SFDA Registration
  • Our Services for IDL(Import Drug Licence) of china CFDA(SFDA)
  • china import drug license (CFDA approval certificate)
  • Cost & Time for Drug China CFDA Registration (Clinical Trials Permission (CTP) Phase)
  • Certification Documents need for chemical drugs SFDA Registration
  • Cost & Time for Drug China CFDA Register(Import Drug Licence (IDL) approval Phase)
  • China Chemical Drug Registration classification regulations
    ( 2007 version)

  • Requisite application documents for Drug CFDA(SFDA) Approval
  • Cost & Time for Drug China CFDA Registration Approval(Clinical Trials Phase)
  • The categories of import drugs in China
  • Application and approval procedure for drugs (1)
  • Application and approval procedure for clinical trials
  • Application and approval procedure for drugs(2)
  • The drugs which can be exempted from clinical trials in China
  • Supplementary application and approval procedure for drugs(1)
  •  Latest Articles
  • China new classification system for chemical drug CFDA registration ( 2016 version)
  • China clinical trial requirements for chemical drug CFDA registration ( 2016 version)
  • China CFDA registration application documents for Class 5.1 Imported Innovative Drugs
  • China CFDA registration application documents for Class 5.2 Imported Generic Drugs
  • China Chemical Drug Registration classification regulations
    ( 2007 version)

  • china import drug license (CFDA approval certificate)
  • Cost & Time for Drug China CFDA Registration (Clinical Trials Permission (CTP) Phase)
  • Cost & Time for Drug China CFDA Registration Approval(Clinical Trials Phase)
  • Cost & Time for Drug China CFDA Register(Import Drug Licence (IDL) approval Phase)
  • The procedure for Import Drug SFDA Registration
  • Our Services for IDL(Import Drug Licence) of china CFDA(SFDA)
  • The categories of import drugs in China
  • Requisite application documents for Drug CFDA(SFDA) Approval
  • The drugs which can be exempted from clinical trials in China
  • Certification Documents need for chemical drugs SFDA Registration
  •   Search Tools
    China National GB Standards Search
    China HS Code Search
    Customs Tariff & Tax Search
    CIQ Import Inspection Requirements Search
    China Cosmetics Formula Ingredients Analysis System
    China Foods Formula Ingredients Analysis System
    Contact Us
    Post Message
    info@sfdachina.com
    rjschina
    +86-400-6578191
      |  Home  |  About Us  |  Our Service   |   China Regulations News  |  Contact Us  |

    +86-400-6578191        info@sfdachina.com 
    106# Zhongmao Mansion,No.1 Beizhan Road, Shenzhen,China 518000
    ©  RJS Copyright  2001-2017 All Rights Reserved



    www.GBstandards.org