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Regulatory Affairs and Legislation Gene Therapy

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Conducting gene therapy clinical trials with genetically modified organisms as the vectors presents unique safety and infection control issues. The area is governed by a range of legislation and guidelines, some unique to this field, as well as those pertinent to any area of clinical work. Gene therapy legislation aims at protecting the human subject, the general public and the environment. This site is an attempt to give an overview of the different regulations and guidelines in <a href="/europe.html">Europe</a> (nearly all countries including European member states), <a href="/united-states-of-america.html">United States of America</a> and the rest of the world. <p>Quick links to major regulatory institutes:<br /><br /> <table border="0" cellspacing="4" cellpadding="0" width="100%"> <tbody> <tr> <td><center><a href="https://osp.od.nih.gov/biotechnology/novel-exceptional-technology-research-advisory-committee/"><img border="0" align="absmiddle" src="/images/dhhs.gif" height="30" /></a></center></td> <td><a style="color: #000000; text-decoration: NONE;" onmouseover="this.style.color='#FF0000'" onmouseout="this.style.color='#000000'" href="https://osp.od.nih.gov/biotechnology/novel-exceptional-technology-research-advisory-committee/" target="_blank">Novel and Exceptional Technology and Research Advisory Committee (NExTRAC)</a></td> </tr> <tr> <td><center><a href="https://www.fda.gov/about-fda/office-medical-products-and-tobacco/about-center-biologics-evaluation-and-research-cber"><img border="0" align="absmiddle" src="/images/FDA.jpg" height="30" /></a></center></td> <td><a style="color: #000000; text-decoration: NONE;" onmouseover="this.style.color='#FF0000'" onmouseout="this.style.color='#000000'" href="https://www.fda.gov/about-fda/office-medical-products-and-tobacco/about-center-biologics-evaluation-and-research-cber" target="_blank">Center for Biologics Evaluation and Research (FDA - CBER)</a></td> </tr> <tr> <td><center><a href="https://ec.europa.eu/growth/sectors/biotechnology_en" target="_blank"><img border="0" align="absmiddle" src="/images/EU.jpg" height="30" /></a></center></td> <td><a style="color: #000000; text-decoration: NONE;" onmouseover="this.style.color='#FF0000'" onmouseout="this.style.color='#000000'" href="https://ec.europa.eu/growth/sectors/biotechnology_en" target="_blank"> European Union - Biotechnology (EU)</a></td> </tr> <tr> <td><center><a href="https://www.ema.europa.eu/" target="_blank"><img border="0" align="absmiddle" src="/images/ema-logo.jpg" height="30" /></a></center></td> <td><a style="color: #000000; text-decoration: NONE;" onmouseover="this.style.color='#FF0000'" onmouseout="this.style.color='#000000'" href="https://www.ema.europa.eu/" target="_blank"> The European Medicines Agency (EMA)</a></td> </tr> <tr> <td><center><a href="https://www.ich.org" target="_blank"><img border="0" align="absmiddle" src="/images/ich.gif" height="30" /></a></center></td> <td><a style="color: #000000; text-decoration: NONE;" onmouseover="this.style.color='#FF0000'" onmouseout="this.style.color='#000000'" href="https://www.ich.org" target="_blank"> Gene Therapy Discussion Group of The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)</a></td> </tr> </tbody> </table> <p>&nbsp;</p> <center><br /> <center> <style> .aangepast { width: 320px; } @media(min-width: 500px) { .aangepast { width: 468px; } ) @media(min-width: 800px) { .aangepast { width: 468px; } } </style> <script async src="https://pagead2.googlesyndication.com/pagead/js/adsbygoogle.js"></script> <ins class="adsbygoogle aangepast" style="display:block; text-align:center;" data-ad-layout="in-article" data-ad-format="fluid" data-ad-client="ca-pub-1253043591735915" data-ad-slot="5059787231"></ins> <script> (adsbygoogle = window.adsbygoogle || []).push({}); </script> </center> <br /> <div class="moduletable "> <div class="mod-banners bannergroup"> <div class="mod-banners__item banneritem"> <a href="/component/banners/click/168.html" target="_blank" rel="noopener noreferrer" title="PeptalkVectorsTargetedDelivery-jan2025"> <img src="https://www.genetherapynet.com/images/banners/PeptalkVectorsTargetedDelivery-jan2025.jpg#joomlaImage://local-images/banners/PeptalkVectorsTargetedDelivery-jan2025.jpg?width=650&height=83" alt="PeptalkVectorsTargetedDelivery-jan2025" > </a> </div> </div> </div> </center><br /> <div align="right"><a href="#top"><span style="font-size: xx-small;" size="1">^ Back to Top</span></a></div> </p></div> </div></div> </div> </div> </div> <div class="uk-width-1-4@m uk-width-1-5@l rechts"> <div> <div class="uk-grid uk-child-width-1-1 uk-grid-row-small"> <div> <div class="uk-panel _menu menulist" id="module-42"> <h3> Legislation Menu </h3> <ul class="uk-nav uk-nav-default uk-nav-accordion" uk-nav="targets: &gt; 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