20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic

• In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator. • The Scheme provides science-based assessment of the potential risks of gene...

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Autores principales: O’Sullivan, Gabrielle M., Philips, Joshua G., Mitchell, Heidi J., Dornbusch, Michael, Rasko, John E. J.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Medicine
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9127347/
https://www.ncbi.nlm.nih.gov/pubmed/35620726
http://dx.doi.org/10.3389/fmed.2022.883434
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author O’Sullivan, Gabrielle M.
Philips, Joshua G.
Mitchell, Heidi J.
Dornbusch, Michael
Rasko, John E. J.
author_facet O’Sullivan, Gabrielle M.
Philips, Joshua G.
Mitchell, Heidi J.
Dornbusch, Michael
Rasko, John E. J.
author_sort O’Sullivan, Gabrielle M.
collection PubMed
description • In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator. • The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment. • It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective. • Recent reforms to the Scheme contribute to, and anticipate, the continued safe development and delivery of gene-based human therapeutics in Australia as a successful model for other jurisdictions.
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spelling pubmed-91273472022-05-25 20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic O’Sullivan, Gabrielle M. Philips, Joshua G. Mitchell, Heidi J. Dornbusch, Michael Rasko, John E. J. Front Med (Lausanne) Medicine • In contrast to the prior voluntary system, since 2001, gene technology in Australia has been regulated under a legislated national Gene Technology Regulatory Scheme which is administered by the Gene Technology Regulator. • The Scheme provides science-based assessment of the potential risks of gene technology to the health and safety of people and the environment. • It complements the role of the Australian Therapeutic Goods Administration which regulates all therapeutic products in Australia to ensure they are safe and effective. • Recent reforms to the Scheme contribute to, and anticipate, the continued safe development and delivery of gene-based human therapeutics in Australia as a successful model for other jurisdictions. Frontiers Media S.A. 2022-05-10 /pmc/articles/PMC9127347/ /pubmed/35620726 http://dx.doi.org/10.3389/fmed.2022.883434 Text en Copyright © 2022 O’Sullivan, Philips, Mitchell, Dornbusch and Rasko. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Medicine
O’Sullivan, Gabrielle M.
Philips, Joshua G.
Mitchell, Heidi J.
Dornbusch, Michael
Rasko, John E. J.
20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic
title 20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic
title_full 20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic
title_fullStr 20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic
title_full_unstemmed 20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic
title_short 20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic
title_sort 20 years of legislation - how australia has responded to the challenge of regulating genetically modified organisms in the clinic
topic Medicine
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9127347/
https://www.ncbi.nlm.nih.gov/pubmed/35620726
http://dx.doi.org/10.3389/fmed.2022.883434
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