Health Canada Regulatory Framework

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Health Canada 2024 to 2026 Forward Regulatory Plan - Canada.ca

(2 days ago) The Forward Regulatory Plan for 2024 to 2026 gives information on regulatory initiatives that Health Canada will be proposing or finalizing in the next 2 years through: pre-publication in the Canada Gazette, Part I. final publication in the Canada Gazette, Part II. We may also include regulatory initiatives … See more

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan.html

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Health Canada’s Proposal for Clinical Trials Regulatory …

(4 days ago) WEBPublished on July 16, 2021. On May 20, 2021 Health Canada opened a consultation on its proposal to modernize the regulatory framework for clinical trials related to human drugs, medical devices, non-prescription …

https://capra.ca/en/blog/health-canadas-proposal-for-clinical-trials-regulatory-modernization-2021-07-16

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Guidance Document

(2 days ago) WEBHealth Canada recognizes that: i. any change to a drug may impact the safety, efficacy and quality of that drug, and ii. any change to the information associated with the drug (e.g., …

https://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-31-2019-eng.pdf

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From sandbox to pandemic: Agile reform of Canadian drug …

(3 days ago) WEBBudget 2019 noted that the clinical trial framework in the health care sector would be modernized, and a regulatory sandbox would be established for the approval …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8123380/

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Health Canada: Framework for Science and Excellence

(2 days ago) WEBWithin Health Canada (HC), regulatory branches rely heavily on science to deliver on a mandate to help Canadians maintain and improve their health. Regulatory branches …

https://publications.gc.ca/collections/collection_2023/sc-hc/H129-141-2022-eng.pdf

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Health Canada to modernise its clinical trial regulations

(5 days ago) WEBFigure 1: The regulatory foundation for the future of clinical trials in Canada is based on a single framework for all health products. The new regulatory regime …

https://www.europeanpharmaceuticalreview.com/news/156664/health-canada-to-modernise-its-clinical-trial-regulations/

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Current state of Health Canada regulation for cellular and gene …

(7 days ago) WEBThe regulatory framework consists of laws passed by Parliament that govern the regulation of Canada's cell and gene therapy products (CGTPs) industry, and …

https://www.sciencedirect.com/science/article/pii/S1465324919300416

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Canadian Regulatory Framework and Regulatory Requirements

(1 days ago) WEBThe ATP framework allows Health Canada to customize regulatory requirements for these products to maintain appropriate, yet flexible, regulatory …

https://link.springer.com/chapter/10.1007/978-3-031-34567-8_6

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Canada: Health Canada's Modernized Clinical Trial Framework

(9 days ago) WEBUnder the modernized clinical trial regulatory framework, Health Canada would similarly have the authority to impose terms and conditions on a case-by-case …

https://www.mondaq.com/canada/healthcare/1085754/health-canadas-modernized-clinical-trial-framework-implications-for-stakeholders

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Canadian Regulatory Framework and Regulatory Requirements for …

(1 days ago) WEBHealth Canada regulates gene therapy products and many cell therapy products as biological drugs under the Canadian Food and Drugs Act and its attendant regulations. …

https://pubmed.ncbi.nlm.nih.gov/37526844/

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Health Canada Modernizing the Regulatory Framework for

(3 days ago) WEBJune 11, 2021 By dicentra. In May of 2021, Health Canada announced a proposal to modernize the regulatory framework for Clinical Trials. This proposal hopes to help …

https://dicentra.com/blog/clinical-trials/health-canada-proposing-to-modernize-the-regulatory-framework-for-clinical-trials

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Regulatory Decision Making in Canada—Exploring New …

(Just Now) WEBof Health Canada’s Regulatory Transparency and Openness Framework aim to enhance the transparency of the regulatory review processes, and to provide public information …

https://www.valueinhealthjournal.com/article/S1098-3015(16)30140-1/pdf

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About The Canadian Quality & Patient Safety Framework for …

(6 days ago) WEBThe Canadian Quality and Patient Safety Framework for Health Services is the first of its kind in Canada. It spearheads a coordinated effort to align stakeholders and providers in …

https://www.healthcareexcellence.ca/en/resources/canadian-quality-and-patient-safety-framework-for-health-services/about-cqps-framework-for-health-services/

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CER – Regulatory Framework Plan: 2023 to 2026

(8 days ago) WEBThe Regulatory Framework Plan (the Plan) is a tool produced by the Canada Energy Regulator (CER) that supports planning and communication. The Plan describes which …

https://www.cer-rec.gc.ca/en/about/how-we-regulate/plans-for-regulatory-framework/regulatory-framework-plan/index.html

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Health Canada increasing oversight of marketed drugs and …

(8 days ago) WEBYu Seon Gadsden-Chung. Health Canada recently proposed amendments to the Food and Drug Regulations (FDR) and the Medical Devices Regulations (MDR) to …

https://www.torys.com/en/our-latest-thinking/publications/2023/06/health-canada-increasing-oversight-of-marketed-drugs-and-medical-devices

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