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    <h1 property="name" id="wb-cont" dir="ltr">
S3A Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling.</h1>




                 
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        <p>June 10, 2016<br> Our reference number: 16-106679-872 </p>
    


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<div class="mwsbodytext text parbase section">
    

    
        <p><strong>Adoption of International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance: </strong>S3A Questions and Answers: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure - Focus on Microsampling.</p>
    


</div>
<div class="mwsbodytext text parbase section">
    

    
        <p>The above referenced draft guidance was released by the ICH Steering Committee for consultation and is being posted on the <a href="http://www.ich.org/products/open-consultation.html"><abbr title="International Council for Harmonisation">ICH</abbr> website</a> for information and comment in accordance with Step 2 of the <abbr title="International Council for Harmonisation">ICH</abbr> process.</p>
    


</div>
<div class="mwsbodytext text parbase section">
    

    
        <p>Please note that draft guidance documents are only made available in English until finalised by the <abbr title="International Council for Harmonisation">ICH</abbr>. It is also important to note that amendments to draft documents may occur as a result of regulatory consultations and subsequent deliberations within the <abbr title="International Council for Harmonisation">ICH</abbr>.</p>
    


</div>
<div class="mwsbodytext text parbase section">
    

    
        <p>All comments forwarded to Health Canada will be transmitted to the <abbr title="International Council for Harmonisation">ICH</abbr> as is, with the disclaimer that they are provided for information and do not necessarily represent the views of Health Canada, except as specifically indicated in separate comments.</p>
    


</div>
<div class="mwsbodytext text parbase section">
    

    
        <p>As appropriate, your organization may alternatively wish to provide comments to your affiliate association in the United States, Europe or Japan for their input directly to <abbr title="International Council for Harmonisation">ICH</abbr>.</p>
    


</div>
<div class="mwsbodytext text parbase section">
    

    
        <p>Comments provided to Health Canada should be submitted <strong>by September 8, 2016</strong> in order to allow sufficient time for their assessment and subsequent transmission to the <abbr title="International Council for Harmonisation">ICH</abbr>.</p>
    


</div>
<div class="mwsbodytext text parbase section">
    

    
        <p>Comments should be directed to:</p>
    


</div>
<div class="mwsbodytext text parbase section">
    

    
        <p>Health Canada ICH Secretariat<br> Bureau of Policy, Science and International Programs<br> Therapeutic Products Directorate<br> Health Products and Food Branch<br> Health Canada<br> 1600 Scott Street, Tunney’s Pasture<br> Ottawa, Ontario<br> K1A 0K9</p>
    


</div>
<div class="mwsbodytext text parbase section">
    

    
        <p>E-mail: <a href="mailto:HPFB_ICH_DGPSA@hc-sc.gc.ca">HPFB_ICH_DGPSA@hc-sc.gc.ca</a><br> Telephone: 613-698-9178<br> Facsimile: 613-941-1812</p>
    


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