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  • 1.  UK GMO process

    This message was posted by a user wishing to remain anonymous
    Posted 15-Mar-2022 10:56
    This message was posted by a user wishing to remain anonymous

    Has anyone recently navigated the MHRA GMO process for gene therapy? I'm looking to find the duration of this process.


  • 2.  RE: UK GMO process

    This message was posted by a user wishing to remain anonymous
    Posted 18-Mar-2022 09:59
    This message was posted by a user wishing to remain anonymous

    This is what I love about regulatory. There are so many areas where there are specialties. I do not have direct experience with this. But, doing some digging, there is a lot of UK guidance on this. One link that provides a good starting point is here (it is a bit dated but still a good starting point): Gene Therapy Legislation in United Kingdom (genetherapynet.com)

    I would also check on the MHRA site for SACGM as it has tons of guidance.
    Original Message


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