Regulatory Open Forum

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  • 1.  Southeast Asia

    This message was posted by a user wishing to remain anonymous
    Posted 01-May-2018 15:12
    This message was posted by a user wishing to remain anonymous

    ​​Can anyone recommend where I can find current information on the regulatory requirements for South East Asia? Specifically, what countries accept whose data.  For example, can I register in Taiwan or Macau with clinical data obtained in Hong Kong?
    Thanks!
    Susan


  • 2.  RE: Southeast Asia

    Posted 08-May-2018 07:46
    Hello Susan,

    Considering South-East Asia, only option is ASEAN member states countries that  have harmonized the regulatory requirements to some extent.
    However, the ASEAN members states do have their own distinct/specific  regulatory requirements.

    The countries that you have mentioned are not part of ASEAN, but there is a possibility of acceptance of clinical data and it needs to be verified from each of the filing country's MOH.

    More details on South East Asian region, can be found on RAPS website itself, under Regulatory Focus, posted on 29th January'2018 titled    " The Drug Regulatory Landscape in the ASEAN Region".

    Hope this helps.


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    PURVI GORADIA
    Manager Regulatory Affairs
    Mumbai
    India
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