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            <idno type="halRefHtml">Hans-Georg Dederer; Gregor Frenken. &lt;i&gt;Genome Editing in Human iPS Cells: A Comparative Legal Analysis of National Regulatory Frameworks for iPSC-based Cell/Gene Therapies&lt;/i&gt;, &lt;a target="_blank" href="https://link.springer.com/book/10.1007/978-3-030-93023-3"&gt;Springer&lt;/a&gt;, pp.83-106, 2022, 978-3-030-93022-6. &lt;a target="_blank" href="https://dx.doi.org/10.1007/978-3-030-93023-3_4"&gt;&amp;#x27E8;10.1007/978-3-030-93023-3_4&amp;#x27E9;&lt;/a&gt;</idno>
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                <title level="m">Genome Editing in Human iPS Cells: A Comparative Legal Analysis of National Regulatory Frameworks for iPSC-based Cell/Gene Therapies</title>
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              <p>The French legal framework on genome editing of human iPS cells is complicated as it relies on multiple applicable laws (European Union law, Council of Europe treaties, and French laws) which are under continual development. It is not specific insofar as neither genome editing nor iPS cells are regulated as such in French law. However, several relevant rules can be identified regarding the access to human biological material (cells, tissues and genes and more specifically somatic cells, germ cells, embryonic cells and embryos) as well as the modalities of their use (prohibition, authorisation under specific conditions, legal gap) for specific purposes (e.g., therapy or research). These regulatory aspects are laid down primarily in EU legislation on tissues and cells and on advanced therapy medicinal products (ATMPs), as well as in French legislation implementing EU law and in the French law on bioethics. Combined gene/cell therapy using genome edited human iPS cells to be differentiated into somatic cells for autologous retransplantation is likely to be considered an application of gene therapy medicinal products either regulated at the EU level as ATMPs in case of manufacturing at an industrial scale or at the French national level under national schemes if not manufactured at an industrial scale.</p>
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