Healthcare Canada Regulatory Review

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Health and Biosciences: Targeted Regulatory Review - canada.ca

(3 days ago) In order to capitalise on the opportunity to review regulatory frameworks in the health and biosciences sector, Health Canada focussed its review on the following frameworks: 1. Canada Consumer Pr… See more

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/targeted-regulatory-reviews/health-biosciences-sector-regulatory-review/roadmap.html

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Health and Biosciences: Targeted Regulatory Review

(5 days ago) WebHealth Canada published a notice of intent in December 2020 on proposed amendments to the Food and Drug Regulations and the Natural Health Products Regulations and …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/targeted-regulatory-reviews/health-biosciences-sector-regulatory-review.html

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Health Canada's Regulatory Stock Review Plan: 2023 to …

(1 days ago) Web2023-07-10. The Regulatory Stock Review Plan is a public list and description of planned reviews of regulations that Health Canada plans to undertake within a three-year …

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

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Health Canada’s regulatory response to COVID-19: Access …

(3 days ago) WebThe COVID-19 pandemic has created an unprecedented demand on Canada's health care system and has led to an urgent need for access to health products. As part of the …

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/regulatory-response-health-product-access.html

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Regulatory innovation for health products: Overview

(Just Now) WebThe need for regulatory innovation for health products. Health Canada is continuously looking ahead to understand the future drivers that will require us to adapt as a regulator. …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/activities-responsibilities/strategies-initiatives/health-products-food-regulatory-modernization.html

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Improving the regulatory review of drugs and devices

(4 days ago) WebImproving the regulatory review of drugs and devices. Health Canada is collaborating with our international partners on issues related to drug and medical device clinical trials, …

https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness/improving-review-drugs-devices.html

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From sandbox to pandemic: Agile reform of Canadian …

(3 days ago) WebHealth Canada, the regulatory authority for health products, had planned to implement the Bill C-97 amendments by early 2021 . In the context of COVID-19, …

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

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Health and Biosciences: Targeted Regulatory Review

(Just Now) WebHealth Canada Electronic Reporting Portal for Controlled Drugs and Substances Latest updates. Health Canada began on-boarding stakeholders in February 2020 and …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/targeted-regulatory-reviews/health-biosciences-sector-regulatory-review/policy-program-initiatives-novel-regulatory-approaches.html

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Forward Regulatory Plan 2022-2024: Regulations …

(2 days ago) WebHealth Products and Food Branch Health Canada. Telephone: 613-321-4235 Email: [email protected]. Date the regulatory initiative was first included in the …

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

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Updates to Health Canada’s regulatory initiatives for 2022-2024, …

(2 days ago) WebAdditionally, the proposed amendments would also clarify that drugs in transhipment through Canada must be in bond. Health Canada has also updated its …

https://www.smartbiggar.ca/insights/publication/updates-to-health-canada-s-regulatory-initiatives-for-2022-2024-and-amendments-to-food-and-drug-regulations-(exports-and-transhipments-of-drugs)

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Health Canada’s regulatory role - Canada.ca

(7 days ago) WebProvide your views when Health Canada makes regulatory decisions. Also learn about the ways we help you to protect and improve your health. Improving the …

https://www.canada.ca/en/health-canada/corporate/mandate/regulatory-role.html

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Current state of Health Canada regulation for cellular and gene …

(7 days ago) WebWe conclude that the risk-benefit approach used by Health Canada for regulatory approval processes is sufficiently flexible to enable to development of novel …

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

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Health Canada Regulatory Modernization: Yesterday, Today, …

(9 days ago) WebRegulatory Enrollment Process (REP) is a recent example of ongoing Health Canada regulatory modernization. On April 22, 2020, while in the midst of COVID-19 initiatives, …

https://www.certara.com/app/uploads/2021/06/WP_Health_Canada_Regulatory_Modernization.pdf

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Health Canada's Proposal to Accelerate New Drug Reviews

(3 days ago) WebHealth Canada began a regulatory review of drugs and devices in 2017, and as part of this process, it issued a “Draft Guidance: Accelerated Review of Human Drug Submissions” …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294445/

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Canada - Healthcare - Updates To Health Canada's Regulatory …

(Just Now) WebAdditionally, the proposed amendments would also clarify that drugs in transhipment through Canada must be in bond. Health Canada has also updated its Regulatory Stock Review Plan: 2022-2024, which is a public list and description of planned reviews of regulations that Health Canada is proposing within a two-year period. The …

https://www.mondaq.com/canada/healthcare/1207650/updates-to-health-canadas-regulatory-initiatives-for-2022-2024-and-amendments-to-food-and-drug-regulations-exports-and-transhipments-of-drugs

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Health Canada’s Proposal for Clinical Trials Regulatory - CAPRA

(4 days ago) WebOn May 20, 2021 Health Canada opened a consultation on its proposal to modernize the regulatory framework for clinical trials related to human drugs, medical …

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

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Health Canada acts and regulations - Canada.ca

(3 days ago) WebHealth Canada publishes the Forward Regulatory Plan, which is a public list of planned or anticipated federal regulatory changes that we intend to make over a 24-month period. Forward Regulatory Plan. We also publish the Stock Review Plan, which is the department's plan to review its entire regulatory stock over a set period of time. The …

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

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Regulatory review of drugs and devices: Expanding priority review

(9 days ago) WebThis project will build new review pathways for those drugs shown to meet health care system needs. The outcome for the people of Canada will be faster access …

https://www.canada.ca/en/health-canada/corporate/transparency/regulatory-transparency-and-openness/improving-review-drugs-devices/expanding-priority-review-pathways-for-drugs-meet-health-care-system-needs.html

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Health Canada Usage of Real World Evidence (RWE) in Regulatory …

(1 days ago) WebPurpose: Between January 2020 and December 2021, Health Canada provided a Summary Basis of Decision (SBD) for each of 110 products approved, including 29 oncology …

https://pubmed.ncbi.nlm.nih.gov/35760071/

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Health Canada Moves To Reduce Regulatory Roadblocks And

(7 days ago) WebHealth Canada has proposed new targeted provisions and regulatory amendments to the Food and Drug Regulations (FDR) and Medical Devices Regulations …

https://www.mondaq.com/canada/healthcare/1306062/health-canada-moves-to-reduce-regulatory-roadblocks-and-enhance-safety-in-health-product-licensing

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Drug Development Timelines: Canada's 30-Day Regulatory Review

(1 days ago) WebAccording to the new EU-CTR regulations, clinical trial review timelines may vary from 60 to 106 days for Part I Assessment (with a comparable timeline for Part II Assessment), in …

https://canada.altasciences.com/resource-center/blog/drug-development-timelines-how-health-canadas-30-day-regulatory-review-process

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A Comprehensive Comparison: FDA vs. Health Canada Regulations

(Just Now) WebThis online training will offer an overview of what Health Canada considers to be a Natural Health product (NHP) and review Canadian regulatory requirements for Natural Health …

https://www.complianceonline.com/resources/fda-vs-health-canada-regulations.html

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Health Canada - Canada.ca

(3 days ago) WebHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …

https://www.canada.ca/en/health-canada.html

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Drug Development Timelines: Canada's 30-Day Regulatory Review

(8 days ago) WebAccording to the new EU-CTR regulations, clinical trial review timelines may vary from 60 to 106 days for Part I Assessment (with a comparable timeline for Part II Assessment), in comparison to the Health Canada default 30-calendar-day review period. Health Canada also has a seven-day turnaround review for eligible comparative, single dose BA

https://www.altasciences.com/resource-center/blog/drug-development-timelines-how-health-canadas-30-day-regulatory-review-process

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Canada: 2023 Highlights in Canadian Life Sciences IP and …

(2 days ago) Web2. PMNOC Regulations: Sixth anniversary of major amendments, court decisions. In June, Health Canada released its Statistical Report 2022/2023 for the …

https://www.mondaq.com/canada/healthcare/1409378/2023-highlights-in-canadian-life-sciences-ip-and-regulatory-law

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Regulatory Pathways Supporting Expedited Drug Development

(Just Now) WebShortened registration pathways These pathways are intended to shorten the regulatory review timelines by health authorities. Regulatory agencies provide additional resources to expedite the review and evaluation of regulatory submissions. Health Canada guidance document, notice of compliance with conditions (NOC/c). 16 …

https://link.springer.com/article/10.1007/s43441-022-00480-3

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Ottawa’s efforts to modernize regulations fail to prioritize public

(Just Now) WebPublished: May 9, 2024 1:42pm EDT. The federal government introduced a recurring annual regulatory modernization bill in 2019 covering all regulatory agencies, including energy, …

https://theconversation.com/ottawas-efforts-to-modernize-regulations-fail-to-prioritize-public-safety-over-profit-229419

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Reviewing Telehealth Legislative and Regulatory Developments

(5 days ago) WebWednesday, May 15, 2024. Print Mail Download i. Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare …

https://natlawreview.com/article/trending-telehealth-april-16-april-22-2024

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Penn Medical Ethics and Health Policy Research Ethics and Policy

(Just Now) WebRegulatory and Ethical Perspectives on Pragmatic Trials: Lessons from Three Cases Mark Neuman, MD, MSc Director, Research Partnerships, Leonard Davis Institute of Health …

https://medicalethicshealthpolicy.med.upenn.edu/master-of-bioethics/new-students/alumni-colloquium-series-2022-23/research-ethics-and-policy-series-reps-three-pragmatic-trials-regulatory-and-ethical-perspectives-mark-neuman-md-msc

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Health Canada eases barriers for sperm and egg donors

(5 days ago) WebUpdated screening rules for sperm and egg donors came into force on Wednesday, Health Canada announced, expanding sperm bank donations from more …

https://www.cbc.ca/news/health/sperm-donation-health-canada-rules-1.7197939

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Labour minister calls for review before dual rail strike can take …

(2 days ago) WebMay 10, 2024 by Kelvin Heppner. A possible rail strike at both of Canada’s main railways could be delayed as the federal labour minister has called for a review of the potential …

https://www.realagriculture.com/2024/05/labour-minister-calls-for-review-before-dual-rail-strike-can-take-place/

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Canada's foreign student push 'mismatched' job market, data shows

(8 days ago) Web2:59. New data obtained by CBC News show that Canada's recruitment of international students failed to match the job market. Colleges and universities brought in …

https://www.cbc.ca/news/canada/toronto/international-students-college-university-fields-study-data-1.7195530

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Frito Lay Canada recalls 2 of its most popular snacks for possible

(4 days ago) WebFrito Lay Canada is recalling two of its most popular snacks due to a possible risk of salmonella contamination.. The recall applies to Sunchips Harvest Cheddar …

https://www.cbc.ca/news/canada/frito-lay-recall-canada-1.7203468

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