Health Canada Drug Submissions Under Review

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Drug and Health Product Submissions Under Review (SUR)

(3 days ago) Find out the status of new and supplemental drug and health product submissions under review by Health Canada. The lists are updated monthly and include information on the medicinal ingredients, therapeutic areas, and decision summaries of the submissions. You can also access lists of former … See more

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

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Guidance Document: The Management of Drug Submissions and …

(8 days ago) WEB6.3 Extraordinary use new drug. Submissions eligible under the criteria in C.08.002.01 (1) of the Food and Drug Regulations may be filed as an Extraordinary Use …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/document.html

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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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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 …

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

(3 days ago) WEBHealth Canada considered New Drug Submissions for 272 NAS from December 2015 until the end of 2022 and approved 257 of them. Fifteen NAS were not …

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

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Update on biosimilars in Canada - October 2021 - Smart & Biggar

(2 days ago) WEBBiosimilar submissions under review. Health Canada provides a monthly update of new drug submissions under review (SUR). Since October 2018, the SUR …

https://www.smartbiggar.ca/insights/publication/update-on-biosimilars-in-canada-october-2021

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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 …

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

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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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Shortening Approval Delays for New Drugs: A Safe - IEDM

(8 days ago) WEBThe first of these is the conditional compliance pathway, for which Health Canada reduces the target timeline to 200 days. (14) Between 2015 and 2019, though, …

https://www.iedm.org/shortening-approval-delays-for-new-drugs-a-safe-straightforward-prescription/

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Update on biosimilars in Canada – March 2023 - Smart & Biggar

(Just Now) WEBBiosimilar submissions under review. Health Canada provides a monthly update of new drug submissions under review (SUR). Since October 2018, the SUR …

https://www.smartbiggar.ca/insights/publication/update-on-biosimilars-in-canada-march-2023

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Priority Review vs NOC/c – Which Pathway is Right for Me?

(Just Now) WEBHealth Canada’s review target for a Priority Review submission is 180 days, just over half the time of a standard New Drug Submission (NDS) review target …

https://intrinsik.com/priority-review-vs-nocc-pathway-right/

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

(2 days ago) WEBSubmissions formerly under review: Supplemental new drug submissions for new uses Publisher - Current Organization Name: Health Canada Licence: Open …

https://open.canada.ca/data/en/info/917dc978-8284-4c2c-8d50-39ab978b3e57

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Oh, Canada: U.S. Patients Don't Want Your Health Policies - Forbes

(4 days ago) WEBJust 30 of the 166 new drugs approved for marketing in Canada between 2018 and 2022 had ended up on public drug formularies by the end of 2023, CHPI …

https://www.forbes.com/sites/sallypipes/2024/04/29/oh-canada-us-patients-dont-want-your-health-policies/

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

(4 days ago) WEBHyperlinks from the Drug and Health Product Submissions Under Review website to the Drug and Health Product Register Health Canada considered New …

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

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Ontario's MedsCheck program could see changes amid allegations …

(3 days ago) WEBAllegations of improper medication reviews at Shoppers Drug Mart, and corporate pressure to hit billing targets for them as outlined in a recent CBC News …

https://www.cbc.ca/news/canada/toronto/ontario-medscheck-program-redesign-1.7186143

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Guidance Document

(6 days ago) WEBGuidance Document: Management of Drug Submissions & Applications 2 Health Canada is responsible for helping Canadians maintain and improve their health. It …

https://www.publications.gc.ca/collections/collection_2021/sc-hc/H164-277-2021-eng.pdf

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

(2 days ago) WEBContact Email: [email protected] Keywords: drug-and-health product submissions; submissions under review; SUR; new-drug submissions …

https://open.canada.ca/data/en/info/75f76896-b4c1-44af-bfed-edeee0eee3a1

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Federal addictions minister says B.C. public decriminalization

(2 days ago) WEBOTTAWA — It is too early to draw conclusions about drug decriminalization, the federal addictions and mental health minister suggested Monday, after British Columbia asked …

https://www.msn.com/en-ca/news/canada/federal-addictions-minister-says-bc-public-decriminalization-reversal-under-review/ar-AA1nSbPd

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