Regulatory Open Forum

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  • 1.  Clinical Trials in China

    Posted 02-May-2014 12:02
    Can you please comment on the length of time it took you to initiate a clinical trial in China to support a global phase 3 program and the key challenges or opportunities and recommendations in conducting a trial in China?  Is there a CRO or authorized representative you would recommend and your experience and is there a good place to better understand the changing regulations in China and better understand the process for clinical trial execution. Lastly when translating documents for a CTA, who did you use and how was the experience and cost.

    Thanks for your input and suggestions,

    Dar


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    Darlene Rosario
    Principal Consultant RA, Quality and Compliance
    Velocity Consulting
    Ventura CA
    United States
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  • 2.  RE:Clinical Trials in China

    Posted 09-May-2014 17:41

    I would like to put comments about basic/general issues.

    CTA preparation: 6-9 months
    CTA ​​evaluation period: 6-12 months
    Issues:
    - Long CTA evaluation period
    - Difficult to obtain the permission to export the clinical blood sample from China
    - Most of the documents needs to be translated into Chinese (CRO can do that)
    - If you would apply the clinical result for the NDA in China, need to follow local requirements (Chinese patients number etc.)

    Regards,
    Yuko
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    Yuko Komokata
    Daiichi Sankyo Co., Ltd.
    Edison NJ
    United States
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    Original Message


  • 3.  RE:Clinical Trials in China

    Posted 06-May-2014 03:59
    CTA application in China is quite long. However, this could be depending on what kinds of products you are applying. If you are applying innovation products, such as NCE the evaluation from CDE will be shorter. It would takes only arround 10~14 months to finish it.

    However, if it is only a generics products, then I am afraid the applicant have to wait for at least 2 years to get the result of application. Common products which have been approved widely in the world would suffer a higher rejection rate than other approval.

    If you need anything, please feel free to contact me.

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    Edmond Liang
    Chinagate Company Limited, Part of Optum
    Shanghai
    China
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    Original Message


  • 4.  RE:Clinical Trials in China

    Posted 06-May-2014 04:08
    Thank you everybody for your help.

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    Yoram Levy
    General Manager
    QSite
    Binyamina
    Israel
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    Original Message


  • 5.  RE: Clinical Trials in China

    Posted 03-Dec-2015 14:58

    I found this discussion thread and wanted to ask an additional question which I would like some help on.  If you are performing a drug clinical trial in China and the registration for one of the medical devices used to monitor the participants expires during the trial, can you continue to use that device for the trial even though its registration has expired and was not renewed?

    Can you start a clinical trial with devices that may no longer have registrations but are in the country in use at the CRO?

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    Margaret Mucha (FRAPS) MS
    Director of Global Regulatory Affairs
    Mortara Instrument Inc.
    Milwaukee WI
    United States

    Original Message