Regulatory Open Forum

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  • 1.  Requirement for Pediatric Plan in Canada

    Posted 11-Apr-2018 05:06
    Hi all,

    In EU the applicant must have an agreed Pediatric Investigation Plan or  waiver in place before submitting a Marketing Authorisation Application.  Otherwise the application will be refused.  Can anyone please advise if there is a similar requirement in Canada?

    Thanks in advance for your steer on this.

    Kind regards

    Karen

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    Karen Real
    Director
    Sliema
    Malta
    ------------------------------


  • 2.  RE: Requirement for Pediatric Plan in Canada

    Posted 16-Apr-2018 02:30
    Hi All,

    No responses to below can anyone help please?

    Thanks

    Karen

    ------------------------------
    Karen Real
    Director
    Sliema
    Malta
    ------------------------------

    Original Message


  • 3.  RE: Requirement for Pediatric Plan in Canada

    Posted 17-Apr-2018 16:25
    ​Hi Karen - My understanding is that there is no requirement in Canada to submit a pediatric plan for a New Drug Submission. On the other hand, the Food and Drug Régulations was amended in 2011 to allow manufacturers to receive a 6-months extension of data protectoin on the provision of results of clinical trials designed to increase knowledge about tolerability and efficacy of a médicine in pediatric use. The pediatric data has to be submitted to Health Canada within 5 years of the initial adult marketing approval.

    Kindest regards,

    Kerry

    ------------------------------
    Kerry Diaz
    Québec QC
    Canada
    ------------------------------

    Original Message


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