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10.1016/j.healthpol.2021.04.018 http://scihub22266oqcxt.onion/10.1016/j.healthpol.2021.04.018 34090723!8123380!34090723     free     free     free Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 209.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       Health+Policy 2021 ; 125 (9): 1115-1120 Nephropedia Template TP {{tp|p=34090723|t=2021. From sandbox to pandemic: Agile reform of Canadian drug regulation |pdf=|usr=}}{{34090723}} gab.com Text From sandbox to pandemic: Agile reform of Canadian drug regulation JO: Health Policy http://www.kidney.de/pget.php?&tw=1&pmid=34090723 #FOAvip 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. Twit Text FOAVip From sandbox to pandemic: Agile reform of Canadian drug regulation ????Health Policy http://www.kidney.de/pget.php?&tw=1&pmid=34090723 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=34090723 #FOAvip English Wikipedia <ref>{{Cite pmid|34090723}}</ref> From sandbox to pandemic: Agile reform of Canadian drug regulation #MMPMID34090723 Eren Vural I; Herder M; Graham JE Health Policy 2021[Sep]; 125 (9): 1115-1120 PMID34090723show ga 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. |*COVID-19[MESH] |*Drug and Narcotic Control[MESH] |Canada[MESH] |Humans[MESH] |Pandemics[MESH]From sandbox to pandemic: Agile reform of Canadian drug regulation (epmc).pdf DeepDyve Pubget Overpricing