China Register Category
　

Top Articles
  • The procedure for Import Drug SFDA Registration
  • CFDA Releases Plan to Improve Medical Device Adverse Event Monitoring
  • Our Services for IDL(Import Drug Licence) of SFDA
  • China Supervision and Inspection of Drugs
  • Application and approval procedure for drugs(2)
  • China Launches Review of Medical Device Industry
  • The drugs which can be exempted from clinical trials in China
  • CFDA Reduces Application Requirements for Medical Device License Amendment and Renewal Processes
  • CFDA Issues Guide for Routine Inspections of Medical Device Manufacturers
  • CFDA Issues Proposed Regulations on Medical Devices
  • China Hygiene Supervision and Inspection of Food
  • Application and approval procedure for clinical trials
  • Our Services for IPEL (Import pharmaceutical excipient Licence)
  • China Import Control on GM Agricultural Bioproducts
  • Requisite documents of Drugs SFDA Registration
    		•
    　

    Latest Articles
  • China Hygiene Supervision and Inspection of Food
  • China Supervision and Inspection of Drugs
  • China Supervision and Inspection of Mechanical and Electrical Products Regulations.
  • China Import Control on GM Agricultural Bioproducts
  • China Customs Clearance for Goods Subject to Entry-exit Inspection and Quarantine
  • What is AQSIQ of China?
  • China Issues Special Procedures for Innovative Medical Devices
  • CFDA Issues Guide for Routine Inspections of Medical Device Manufacturers
  • CFDA Releases Draft Good Supply Practices for Medical Devices
  • CFDA Reduces Application Requirements for Medical Device License Amendment and Renewal Processes
  • CFDA Releases Plan to Improve Medical Device Adverse Event Monitoring
  • China Launches Review of Medical Device Industry
  • China Reorganizes the State Food and Drug Administration and Appoints a New Commissioner
  • China FDA Seeks to Improve Medical Device Evaluation at the Provincial and Municipal Government Levels
  • CFDA Publishes Draft Rule on Administrative Procedure for Public Comment
    		•
    　

    　

    　

    　
    　
         Home >> China Regulations News
    　

      the procedure for Import Pharmaceutical Excipient Registration

    ADD DATE:2010-2-20 HITS:3

    In brief, if your products need not to be conducted clinical trials, and the Application Dossier are appropriate, you shall obtain IPEL within about 9 months after submission.

    If clinical trials must be conducted, the general procedure is:

    Step 1. Submitting an application and if the Application Dossier are appropriate, you shall obtain Clinical Trials Permission (CTP) within about 9 months after submission

    Step 2. Conducting the clinical trials.

    Step 3. Submitting the Application Dossier (include the reports of clinical trials) and if the Application Dossier are appropriate, you shall obtain IPEL within about 9 months after submission
    　
    Similar topics:

    　

       >> Contact a RJS expert for more information >>

    　
    　
    　 　
    　

    | +86-400-657-8191 | Guangdong:+86-755-25831330 | Beijing:+86-10-51663836 | Shanghai:+86-21-31255165  |

    RJS MedTech Inc.  ©  Copyright 2000-2015 All Rights Reserved