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Release of Draft (Step 2) International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use: S9 Q&amp;As: Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals</h1>




                 
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        <h2>Notice</h2>
    


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        <p>July 29, 2016<br> Our file number: 16-108194-747</p>
    


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<div class="mwsbodytext text parbase section">
    

    
        <p><strong>Release of Draft (Step 2) International Council for Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH) Guidance:</strong> S9 Q&amp;As: Questions and Answers: Nonclinical Evaluation for Anticancer Pharmaceuticals</p>
    


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<div class="mwsbodytext text parbase section">
    

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The above referenced draft guidance was released by the 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


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<div class="mwsbodytext text parbase section">
    

    
        <p>Please note that draft guidance documents are only made available in English until finalized by the 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>
    


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        <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>
    


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<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>
    


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<div class="mwsbodytext text parbase section">
    

    
        <p>Comments provided to Health Canada should be submitted <strong>by October 27, 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>
    


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


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        <p>Jian Wang<br><a href="https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/biologics-genetic-therapies-directorate/biologics-genetic-therapies-directorate-centres-offices.html">Centre for Evaluation of Radiopharmaceuticals and Biotherapeutics</a><br> Biologics and Genetic Therapies Directorate<br> Health Products and Food Branch<br> Health Canada<br> 100 Eglantine Driveway, Tunney's Pasture<br> Ottawa, Ontario<br> K1A 0K9</p>
    


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        <p>Email: <a href="mailto:Jian.wang@hc-sc.gc.ca">Jian.wang@hc-sc.gc.ca</a><br> Telephone: 613-293-1849<br> Facsimile: 613-946-0639</p>
    


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