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From sandbox to pandemic: Agile reform of Canadian drug regulation()
Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new "agile" licensing framework known as the "Advanced The...
Autores principales: | , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier B.V.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8123380/ https://www.ncbi.nlm.nih.gov/pubmed/34090723 http://dx.doi.org/10.1016/j.healthpol.2021.04.018 |
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author | Eren Vural, Ipek Herder, Matthew Graham, Janice E. |
author_facet | Eren Vural, Ipek Herder, Matthew Graham, Janice E. |
author_sort | Eren Vural, Ipek |
collection | PubMed |
description | Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, however, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada's COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID-19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amendments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement. |
format | Online Article Text |
id | pubmed-8123380 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | Elsevier B.V. |
record_format | MEDLINE/PubMed |
spelling | pubmed-81233802021-05-17 From sandbox to pandemic: Agile reform of Canadian drug regulation() Eren Vural, Ipek Herder, Matthew Graham, Janice E. Health Policy Health Reform Monitor Public health urgency for emerging COVID-19 treatments and vaccines challenges regulators worldwide to ensure safety and efficacy while expediting approval. In Canada, legislative amendments by 2019 Omnibus Bill C-97 created a new "agile" licensing framework known as the "Advanced Therapeutic Pathway" (ATPathway) and modernized the regulation of clinical trials of drugs, vaccines, and medical devices. Bill C-97′s amendments are worthy of attention in Canada and globally, as health product regulation bends to COVID-19. The amendments follow reforms elsewhere to accommodate health product innovation, however, the Canadian ATPathway is broader and more flexible than its counterparts in other jurisdictions. In addition, Bill C-97 informed Canada's COVID-19 response in important ways, particularly in relation to clinical trials. The measures adopted by the drug regulatory authority, Health Canada (HC) during COVID-19 may become the new norm in Canadian regulatory practice insofar as they help achieve the amendments introduced by Bill C-97. Finally, despite government rhetoric of transparency, the agenda-setting, formulation, and implementation of the amendments have occurred with little opportunity for scrutiny or public engagement. Elsevier B.V. 2021-09 2021-05-15 /pmc/articles/PMC8123380/ /pubmed/34090723 http://dx.doi.org/10.1016/j.healthpol.2021.04.018 Text en © 2021 Elsevier B.V. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active. |
spellingShingle | Health Reform Monitor Eren Vural, Ipek Herder, Matthew Graham, Janice E. From sandbox to pandemic: Agile reform of Canadian drug regulation() |
title | From sandbox to pandemic: Agile reform of Canadian drug regulation() |
title_full | From sandbox to pandemic: Agile reform of Canadian drug regulation() |
title_fullStr | From sandbox to pandemic: Agile reform of Canadian drug regulation() |
title_full_unstemmed | From sandbox to pandemic: Agile reform of Canadian drug regulation() |
title_short | From sandbox to pandemic: Agile reform of Canadian drug regulation() |
title_sort | from sandbox to pandemic: agile reform of canadian drug regulation() |
topic | Health Reform Monitor |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8123380/ https://www.ncbi.nlm.nih.gov/pubmed/34090723 http://dx.doi.org/10.1016/j.healthpol.2021.04.018 |
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