Health Canada New Drug Submission 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 … 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): New …

(4 days ago) WEB597 rows · Submissions formerly under review: New drug submissions Medicinal Ingredient(s) Therapeutic Area Submission Control Number Year, Month Submission …

https://www.canada.ca/en/health-canada/services/drug-health-product-review-approval/submissions-under-review/new-drug-submissions-completed.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'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ago) WEBHealth Canada began a regulatory review of drugs and devices in 2017, and as part of this process, it issued a “Draft Guidance: Accelerated Review of Human Drug …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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New drug submissions in Canada and a comparison with the …

(7 days ago) WEBNON-W were identified through the New Drug Submissions on its Drug and Health Product Submissions Under Review website and the generic name of the …

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

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

(4 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://www.ncbi.nlm.nih.gov/pmc/articles/PMC10270583/

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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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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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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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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 submission in Canada Health Canada data

(Just Now) WEBNew drug submissions in Canada and a comparison with the Food and Drug Administration and the European Medicines Agency: Cross-sectional analysis. Joel …

https://www.pharmafocuseurope.com/researchinsights/new-drug-submissions-in-canada-and-a-comparison-with-the-food-and-drug-administration-and-the-european-medicines-agency

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Publication of the Health Canada Guidance Document: Quality …

(2 days ago) WEBPublication of the Health Canada Guidance Document: Quality (Chemistry and Manufacturing) Guidance: New Drug Submissions (NDSs) and Abbreviated New …

https://open.canada.ca/data/en/info/89e44fc0-5ead-423b-a518-b6bf2e604c02

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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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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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New Drug Submission (NDS) for Canada - Freyr Solutions

(2 days ago) WEBHealth Canada’s New Drug Submission (NDS) is the process through which new drugs are approved and controlled by the Canadian Health Authority before entering the …

https://regulatoryaffairs.freyrsolutions.com/new-drug-submission-nds-health-canada

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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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