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  • 1.  Companion diagnostic feedback for NMPA CMDE needed

    Posted 20-Aug-2020 15:17

    In past several months, NMPA released a few guidelines looking for feedback in the CDx area both from its technical and clinical review departments on the device side. The most recent one, "Clinical Trials Guidelines for Companion Diagnostic Reagents for Approved Anti-tumor Drugs (draft for feedback)" is published on August 13, 2020. The feedback comments are due on Sept 10th.  It is a great opportunity to have your opinions heard by NMPA CMDE on CDx. 

    This guidance is the first one specifically drafted for the clinical trial of CDx products to support the already approved anti-tumor drugs on the market.  China NMPA has been lagging behind its counterparts in the US and FDA in issuing guidance regulating CDx area. This draft for feedback along with the WIP guideline for unapproved anti-tumor drugs, "Technical Review Guideline of Clinical Trial for Co-development of CDx Reagents and Anti-Tumor Drugs (WIP)" will shape how the NMPA reviewers will evaluate CDx for approval, how manufacturers must comply in order to have their CDx approved in China. 

    In addition to the above two clinical guidance for CDx used with approved and unapproved anti-tumor drugs, another guidance document were released for feedback from the technical review departments "Revisions for instructions for use and technical review of tumor companion diagnostics based on similar therapeutic drugs (draft)"  on July 7 2020 (comment were already due on Aug 3, 2020).

    The increased frequency of the CDx guidance suggests that NMPA CMDE is starting to pay more attention and intends to regulate more in the CDx domain. These guidelines could have significant implications for both the IVD side and anti-tumor therapeutic drug manufacturers.



    ------------------------------
    Grace Fu Palma
    ChinaMed Device, LLC
    MA, U.S.
    gpalma@ChinaMedDevice.com
    978-390-4453
    www.ChinaMedDevice.com
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  • 2.  RE: Companion diagnostic feedback for NMPA CMDE needed

    Posted 24-Aug-2020 23:03
      |   view attached
    Thanks Grace for this.  CDx have long been a challenging topic in China and it's good to see this very detailed and thoughtful draft guidance coming out of CMDE.

    If readers want to look at the original you can dowload it (in Mandarin) from https://www.cmde.org.cn/CL0065/21446.html 

    We have also prepared an UNOFFICAL English translation which is attached to this post.

    Of course the guidance talks in detail around the specific clinical trial designs expected for CDx for use with already approved pharmaceuticals.  It's a different story for primary Pharma/CDx combination trials for the new medicines approval.

    Arthur 


    ------------------------------
    Arthur Brandwood PhD FRAPS
    Director and Principal Consultant
    Brandwood CKC
    Sydney, Australia
    Arthur.brandwood@brandwoodckc.com
    www.brandwoodckc.com
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    Attachment(s)

    pdf
    CMDE CDx Guidance Draft for Comment EN.pdf   418 KB 1 version
    Original Message


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