Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada
Canadian academic and industry stakeholders are concerned about the inclusion of “virus-like particles or sub-viral particles” in the definition of New Substances Notification Regulations for Organisms (NSNR(O)) which impacts clinical cell and gene therapy and commercialization. The requirement of a...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2019-03-01
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| Series: | Frontiers in Medicine |
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| Online Access: | https://www.frontiersin.org/article/10.3389/fmed.2019.00058/full |
| _version_ | 1819118083677093888 |
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| author | Tania Bubela Ron Boch Sowmya Viswanathan Sowmya Viswanathan Sowmya Viswanathan Sowmya Viswanathan |
| author_facet | Tania Bubela Ron Boch Sowmya Viswanathan Sowmya Viswanathan Sowmya Viswanathan Sowmya Viswanathan |
| author_sort | Tania Bubela |
| collection | DOAJ |
| description | Canadian academic and industry stakeholders are concerned about the inclusion of “virus-like particles or sub-viral particles” in the definition of New Substances Notification Regulations for Organisms (NSNR(O)) which impacts clinical cell and gene therapy and commercialization. The requirement of an independent 120 days Environment and Climate Change Canada (ECCC) review preceding a Health Canada review on quality and environmental concerns places an additional burden on Sponsors submitting clinical trial applications (CTA) and/or New Drug Submissions (NDS). A workshop initiated by CellCAN and BIOTECanada with participants from Environment and Climate Change Canada, Health Canada, the Public Health Agency of Canada and Innovation, Science and Economic Development (Ottawa, March 19, 2018) with invited stakeholders discussed approaches to streamline the environmental review process. The following main recommendations were the focus of the workshop:
A regulatory policy to clarify Canadian Environmental Protection Act (CEPA)'s definition of “living organism.” This is currently defined as “a substance that is an animate product of biotechnology.” A regulatory policy could potentially exempt “human cells touched by biotechnology for use in human medicinal products” from this definition to clarify any unintended overreach of CEPA, particularly as it applies to non-genetically modified cell therapies.A guidance document to better interpret NSNR(O) Schedule 1 requirements by CTA/NDS sponsors to satisfy the environmental review process.An amendment at the level of regulations, to the NSNR (O) to create a deferment to postpone environmental assessment of micro-organisms used in the manufacturing during investigational clinical trials (pre-market stage). The regulations would apply at the time of market authorization evaluation and review, when sufficient clinical data on vector shedding has been collected, as part of the investigational clinical trials.Amendment to Schedule 4 of the CEPA to include the Food and Drugs Act and Regulations (Food and Drugs Act /FDR) as an exclusion to the application of CEPA. This would remove the current dual regulation of cell and gene therapies by both CEPA and Food and Drugs Act /FDR.These recommendations and other options were discussed at the workshop. These recommendations if adopted will significantly streamline the current regulatory burden and harmonize environmental assessment requirements with other jurisdictions. |
| first_indexed | 2024-12-22T05:43:14Z |
| format | Article |
| id | doaj.art-bc75517d72444008bdcecc980e5bc200 |
| institution | Directory Open Access Journal |
| issn | 2296-858X |
| language | English |
| last_indexed | 2024-12-22T05:43:14Z |
| publishDate | 2019-03-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Medicine |
| spelling | doaj.art-bc75517d72444008bdcecc980e5bc2002022-12-21T18:37:08ZengFrontiers Media S.A.Frontiers in Medicine2296-858X2019-03-01610.3389/fmed.2019.00058447575Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in CanadaTania Bubela0Ron Boch1Sowmya Viswanathan2Sowmya Viswanathan3Sowmya Viswanathan4Sowmya Viswanathan5Faculty of Health Sciences, Simon Fraser University, Burnaby, BC, CanadaBIOTECanada, Ottawa, ON, CanadaArthritis Program, Krembil Research Institute, University Health Network, Toronto, ON, CanadaCell Therapy Program, University Health Network, Toronto, ON, CanadaInstitute of Biomaterials and Biomedical Engineering, University of Toronto, Toronto, ON, CanadaDivision of Hematology, Department of Medicine, University of Toronto, Toronto, ON, CanadaCanadian academic and industry stakeholders are concerned about the inclusion of “virus-like particles or sub-viral particles” in the definition of New Substances Notification Regulations for Organisms (NSNR(O)) which impacts clinical cell and gene therapy and commercialization. The requirement of an independent 120 days Environment and Climate Change Canada (ECCC) review preceding a Health Canada review on quality and environmental concerns places an additional burden on Sponsors submitting clinical trial applications (CTA) and/or New Drug Submissions (NDS). A workshop initiated by CellCAN and BIOTECanada with participants from Environment and Climate Change Canada, Health Canada, the Public Health Agency of Canada and Innovation, Science and Economic Development (Ottawa, March 19, 2018) with invited stakeholders discussed approaches to streamline the environmental review process. The following main recommendations were the focus of the workshop: A regulatory policy to clarify Canadian Environmental Protection Act (CEPA)'s definition of “living organism.” This is currently defined as “a substance that is an animate product of biotechnology.” A regulatory policy could potentially exempt “human cells touched by biotechnology for use in human medicinal products” from this definition to clarify any unintended overreach of CEPA, particularly as it applies to non-genetically modified cell therapies.A guidance document to better interpret NSNR(O) Schedule 1 requirements by CTA/NDS sponsors to satisfy the environmental review process.An amendment at the level of regulations, to the NSNR (O) to create a deferment to postpone environmental assessment of micro-organisms used in the manufacturing during investigational clinical trials (pre-market stage). The regulations would apply at the time of market authorization evaluation and review, when sufficient clinical data on vector shedding has been collected, as part of the investigational clinical trials.Amendment to Schedule 4 of the CEPA to include the Food and Drugs Act and Regulations (Food and Drugs Act /FDR) as an exclusion to the application of CEPA. This would remove the current dual regulation of cell and gene therapies by both CEPA and Food and Drugs Act /FDR.These recommendations and other options were discussed at the workshop. These recommendations if adopted will significantly streamline the current regulatory burden and harmonize environmental assessment requirements with other jurisdictions.https://www.frontiersin.org/article/10.3389/fmed.2019.00058/fullenvironmental concernsrisk assessmentstreamlined reviewregulatory burdenclinical trialsimmunotherapy |
| spellingShingle | Tania Bubela Ron Boch Sowmya Viswanathan Sowmya Viswanathan Sowmya Viswanathan Sowmya Viswanathan Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada Frontiers in Medicine environmental concerns risk assessment streamlined review regulatory burden clinical trials immunotherapy |
| title | Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada |
| title_full | Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada |
| title_fullStr | Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada |
| title_full_unstemmed | Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada |
| title_short | Recommendations for Regulating the Environmental Risk of Shedding for Gene Therapy and Oncolytic Viruses in Canada |
| title_sort | recommendations for regulating the environmental risk of shedding for gene therapy and oncolytic viruses in canada |
| topic | environmental concerns risk assessment streamlined review regulatory burden clinical trials immunotherapy |
| url | https://www.frontiersin.org/article/10.3389/fmed.2019.00058/full |
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