Regulatory Open Forum

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  • 1.  China legal agent

    Posted 20-Feb-2020 04:55
    Hi,
    Our legal agent for China have increased their fees by 10 times because of changes in regulations and the intensity of NMPA supervision . Are any others faced with this situation ? Since change of legal agent is a time consuming and painful exercise, we feel trapped by this sudden announcement . Any advice ?
     
    Thanks & Regards,
     
    Rashmi Pillay
    Regulatory Affairs Manager

    Ellex 
    3-4 Second Avenue
    Mawson Lakes SA, 5095
     
    T + 61 8 7074 8105
    rpillay@ellex.com
    W ellex.com
    .............................................................................
     
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  • 2.  RE: China legal agent

    Posted 21-Feb-2020 04:49
    Hi, it is true that upcoming changes will give more responsibility to local agent.
    But 10 times might be too much, maybe current agent fee is too low?
    The changing process is quite simple and it will take only 4 weeks or so.
    Of course changing label is another extra work, but I feel 10 times is not acceptable, hope you could negotiate.

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    Go Murayama
    Osaka-Shi
    Japan
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