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 te...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-05-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fmed.2022.883434/full |
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| author | Gabrielle M. O’Sullivan Joshua G. Philips Heidi J. Mitchell Michael Dornbusch John E. J. Rasko John E. J. Rasko John E. J. Rasko |
| author_facet | Gabrielle M. O’Sullivan Joshua G. Philips Heidi J. Mitchell Michael Dornbusch John E. J. Rasko John E. J. Rasko John E. J. Rasko |
| author_sort | Gabrielle M. O’Sullivan |
| collection | DOAJ |
| 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. |
| first_indexed | 2024-04-13T03:42:20Z |
| format | Article |
| id | doaj.art-42199189d83c4b49a2b76926e2613b44 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-04-13T03:42:20Z |
| publishDate | 2022-05-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-42199189d83c4b49a2b76926e2613b442022-12-22T03:04:07ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2022-05-01910.3389/fmed.2022.88343488343420 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the ClinicGabrielle M. O’Sullivan0Joshua G. Philips1Heidi J. Mitchell2Michael Dornbusch3John E. J. Rasko4John E. J. Rasko5John E. J. Rasko6Research Ethics and Governance Office, Royal Prince Alfred Hospital, Sydney Local Health District, Sydney, NSW, AustraliaOffice of the Gene Technology Regulator, Australian Government Department of Health, Canberra, ACT, AustraliaOffice of the Gene Technology Regulator, Australian Government Department of Health, Canberra, ACT, AustraliaOffice of the Gene Technology Regulator, Australian Government Department of Health, Canberra, ACT, AustraliaDepartment of Cell and Molecular Therapies, RPA Hospital, SLHD, Sydney, NSW, AustraliaFaculty of Medicine and Health, The University of Sydney, Sydney, NSW, AustraliaGene and Stem Cell Therapy Program, Centenary Institute, The University of Sydney, Sydney, NSW, Australia•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.https://www.frontiersin.org/articles/10.3389/fmed.2022.883434/fullgene technologygene therapyclinical medicinegene technology regulationrisk managementtechnological and regulatory advances |
| spellingShingle | Gabrielle M. O’Sullivan Joshua G. Philips Heidi J. Mitchell Michael Dornbusch John E. J. Rasko John E. J. Rasko John E. J. Rasko 20 Years of Legislation - How Australia Has Responded to the Challenge of Regulating Genetically Modified Organisms in the Clinic Frontiers in Medicine gene technology gene therapy clinical medicine gene technology regulation risk management technological and regulatory advances |
| 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 | gene technology gene therapy clinical medicine gene technology regulation risk management technological and regulatory advances |
| url | https://www.frontiersin.org/articles/10.3389/fmed.2022.883434/full |
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