Regulatory Open Forum

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  • 1.  OTC products in Asia

    Posted 01-Aug-2018 18:16

    We are looking for some resources for regulations to market OTC products in Asian countries.

    At this moment, we just want to do some research, before finding contractors.

    Does anyone know any good resources (ex. books, websites)?

     

    Tami Ujiie, RAC

    Sr. Mgr. International Regulatory Affairs

    Teikoku Pharma USA, Inc.

    Phone: +1-408-501-1822

    Fax: +1-408-501-1922

    E-mail: tujiie@teikokuusa.com

     

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  • 2.  RE: OTC products in Asia

    Posted 02-Aug-2018 08:08
    Hello Tamie,

    Each of the Asian countries has their own country specific requirements for OTC registrations and marketing.
    You can visit each MOH website, however some of them are in their regional language only which can further limits the findings.

    Hence, the most viable option is to check with the local agent/representative with whom your company is going to give contract.
    The local agent always has an advantage to contact the MOH directly and provide requisite information.

    If the above option is ruled out, then you may have to take the help of Regulatory consultants , one of them is "Clarivate Analytics".

    Best Regards

    ------------------------------
    PURVI GORADIA
    Manager Regulatory Affairs
    Mumbai
    India
    ------------------------------



  • 3.  RE: OTC products in Asia

    Posted 03-Aug-2018 13:12
    ​Thank you, Purvi.
    Before signing a contract with a consultant, we would like to do some feasibility research.
    I looked into the MOH websites, but some of them were very hard to navigate.
    I will check "Clarivate Analytics".

    ------------------------------
    Tami Ujiie RAC
    Senior Manager, International Regulatory Affairs
    San Jose CA
    United States
    ------------------------------