Health Canada Drugs Under Review

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Drug and Health Product Submissions Under Review (SUR)

(3 days ago) There are four Submissions Under Review (SUR) Lists, which contain: 1. new drug submissions currently under review 2. supplemental new drug submissions currently under review 3. new drug submissions formerly under review 4. supplemental new drug submissions formerly under review All four lists are updated … See more

https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review.html

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Drug and Health Product Submissions Under Review (SUR

(1 days ago) WebPart of an 'aligned review' with a health technology assessment organization: Pembrolizumab: Antineoplastic agents: 2024-02: Merck Canada Inc: Being reviewed …

https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/supplemental-submissions-under-review.html

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Drug and health product review and approval - Canada.ca

(8 days ago) WebGet approval for drugs, medical devices, natural health products and homeopathic medicine. Also access information on drug pricing and drug approval decisions. Drug …

https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval.html

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Notice: Expansion of the Generic Submissions Under Review List

(7 days ago) WebOur file number: 23-109491-316. The Generic Submissions Under Review (GSUR) List helps make Health Canada's review processes more transparent. The list …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-expansion-generic-submissions-under-review-list.html

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Review decisions - Drug and Health Products Portal

(3 days ago) WebInformation on drug and health products authorized by Health Canada. Skip to main content Supplement to a New Drug Submission - Priority Review. Date Filed / …

https://dhpp.hpfb-dgpsa.ca/review-documents

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Health Canada assessing popular diabetes, weight-loss drugs like

(2 days ago) WebHealth Canada is independently reviewing a class of drugs used in diabetes and weight-loss medications following reports that they may lead to a risk of suicide. In …

https://www.cbc.ca/news/health/health-canada-review-diabetes-weight-loss-1.6921759

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Drug and Health Product Submissions Under Review (SUR)

(2 days ago) WebContact Email: [email protected] Keywords: Drug submission; submissions under review; drug and health product review and approval. Subject: Health and Safety; …

https://open.canada.ca/data/en/info/40b5d9f7-fafc-4a51-8fd9-7847a41401f8

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Drug and Health Product Submissions Under Review (SUR)

(5 days ago) WebHow to access lists of drug submissions currently under review, and lists of certain drug submissions formerly under review. This initiative is funded by Health Canada's …

https://www.substanceusehealth.ca/resource/drug-and-health-product-submissions-under-review-sur

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Is Canada missing out? An assessment of drugs approved - CMAJ

(9 days ago) WebOf 230 new active substances with an approval by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) or both between 2016 …

https://www.cmaj.ca/content/195/23/E815

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Health Canada's Proposal to Accelerate New Drug Reviews

(3 days ago) WebHealth Canada is proposing to update its accelerated review pathways to get important new drugs into the market more quickly. To date, the two pathways that Health Canada …

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

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New drug submissions in Canada and a comparison with the Food …

(4 days ago) Web(The equivalent of the NAS designation by the United States Food and Drug Administration (FDA) is new molecular entity.) Since December 2015, Health Canada …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10270583/

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Therapeutic Products Directorate

(2 days ago) WebDrug Submission Performance Quarterly Report October - December 2021. Health Canada is the federal department responsible for helping the people of Canada maintain and …

https://publications.gc.ca/collections/collection_2022/sc-hc/H167-2-2021-3-eng.pdf

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Health Canada disclosing more information on pending generic …

(6 days ago) WebOn February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic …

https://www.pharmainbrief.com/2024/02/health-canada-disclosing-more-information-on-pending-generic-drug-submissions/

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Is Canada missing out? An assessment of drugs approved …

(3 days ago) WebNot submitted to Health Canada n = 75 Received a Notice of Compliance n = 142 Currently under review n = 8 Failed review* n = 5 New active substances approved internationally …

https://www.cmaj.ca/content/cmaj/195/23/E815.full.pdf

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New drug submissions in Canada and a comparison with the Food …

(3 days ago) WebBackground Health Canada posts the outcomes of all New Drug Submissions. In some cases, companies have withdrawn submissions or submissions …

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0286802

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Canada: List Of Generic Submissions Under Review Now Available

(2 days ago) WebFor submissions accepted into review on or after October 1, 2018, Health Canada now provides the following information: The new, separate Generic Submissions …

https://www.mondaq.com/canada/healthcare/766994/list-of-generic-submissions-under-review-now-available

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Drug and Health Product Submissions Under Review (SUR): New …

(2 days ago) Webdrug-and-health product submissions; Submissions Under Review; SUR; new-drug submissions under-review; Subject: Health and Safety; Maintenance and …

https://open.canada.ca/data/en/info/80106243-6653-4c95-96a0-ee093ea71cbf

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Health Canada's use of priority review status for drugs for unmet …

(7 days ago) WebThis study compared drugs approved by both Health Canada and the FDA to assess agreement on products receiving priority review status utilizing a database of new drugs approved between 1992 and March 2015 in Canada and between 1992 and 2014 in the United States. 27% received approval in 2014; these may be currently under …

https://www.sciencedirect.com/science/article/pii/S027323001530043X

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Decriminalization of certain drugs under review say feds

(2 days ago) WebApr 29, 2024. The federal minister for addictions and mental health says it’s too early to draw conclusions about drug decriminalization after British Columbia asked …

https://www.aptnnews.ca/national-news/federal-addictions-minister-says-b-c-public-decriminalization-reversal-under-review/

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Health Canada's Proposal to Accelerate New Drug Reviews

(1 days ago) Webin English, French. Health Canada is proposing to update its accelerated review pathways to get important new drugs into the market more quickly. To date, the two pathways that …

https://pubmed.ncbi.nlm.nih.gov/32538346/

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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 Product InfoWatch: April 2024 - Canada.ca

(7 days ago) Web1. Sulfatrim, Sulfatrim DS, Sulfatrim Pediatric (sulfamethoxazole and trimethoprim tablets USP) [product monograph]. Vaughan (ON): AA Pharma Inc.; 2023. …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/health-product-infowatch/april-2024.html

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Mixed reviews as B.C. significantly rolls back drug decriminalization

(5 days ago) WebCBC News · Posted: Apr 26, 2024 8:21 PM PDT Last Updated: April 27. Fentanyl is pictured during the first day of decriminalization of drugs in British Columbia …

https://www.cbc.ca/news/canada/british-columbia/drug-decriminalization-roll-back-reax-1.7187035

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The Drug Review and Approval Process in Canada – An eGuide

(Just Now) WebPhase 2 – The Effectiveness phase. In this phase, the drug is given to a larger group of individuals with the pathology to be treated (usually several hundred). The purpose is to …

https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/

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CADTH Is Now Canada’s Drug Agency CDA-AMC

(5 days ago) WebNews. CADTH Is Now Canada’s Drug Agency. May 1, 2024. In December 2023, it was announced that Canada’s Drug Agency would be built from CADTH. The …

https://www.cadth.ca/news/cadth-now-canadas-drug-agency

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