Health Canada Drug Submission List

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Drug and Health Product Submissions Under Review …

(3 days ago) The Submissions Under Review (SUR) Lists include submissions filed under the Food and Drug Regulationsfor use in relation to the COVID-19 pandemic. These submissions are identified under the submission 'class' column. To find these submissions, type "COVID" into the "Filter items" box at the top of … 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 …

(8 days ago) WebIn order to maintain consistency and enhance transparency, this guidance was updated in July 2019 to reflect the most current information, processes and …

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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Generic submissions under review - Open Government …

(9 days ago) WebGeneric submissions under review Generic submissions under review How to access a list of generic drug submissions currently under review. 2020-09-17 Health Canada …

https://open.canada.ca/data/info/b5276b5c-64e1-46ed-b09e-fffe5a4596b4

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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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Review decisions - Drug and Health Products Portal

(3 days ago) WebNew Drug Submission (New Active Substance) - Notice of Compliance with Conditions (21) New Drug Submission - Priority Review (14) Application filed under section 3 of the …

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

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Coming Soon: Updated Generic Submissions Under Review List

(7 days ago) WebThe GSUR List currently identifies the medicinal ingredient (s), therapeutic area, and number of generic submissions under review with Health Canada. Health …

https://www.mccarthy.ca/en/insights/blogs/techlex/coming-soon-updated-generic-submissions-under-review-list

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Canada: Coming Soon: Updated Generic Submissions Under …

(6 days ago) WebHealth Canada has published its long anticipated notice regarding changes to the Generic Submissions Under Review (GSUR) List. 1. The GSUR List currently …

https://www.mondaq.com/canada/healthcare/1444184/coming-soon-updated-generic-submissions-under-review-list

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Guidance document : preparation of regulatory activities in the

(1 days ago) WebThis guidance document is to be used in the preparation and filing of drug regulatory activities to Health Canada in the eCTD electronic-only format as established by the …

https://publications.gc.ca/site/eng/9.882674/publication.html

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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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The Pathway for New Cancer Drug Access in Canada - PMC

(3 days ago) WebThe Health Products and Food Branch (HPFB) is the section of Health Canada that reviews a new drug seeking market access when a formal “New Drug …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870298/

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Health Canada updates Guidance Document: The Management of …

(9 days ago) WebAuthored by Katie Lee. September 30, 2019. On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of …

https://www.smartbiggar.ca/insights/publication/health-canada-updates-guidance-document-the-management-of-drug-submissions-and-applications

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Prescription Drug List - Drug and Health Product Register

(9 days ago) Web2013-12-19. 4-Hydroxycoumarin or its derivatives. Acenocoumarol. when sold or recommended as anticoagulants. 2013-12-19. 5-Aminosalicylic acid. Mesalazine. 2013 …

https://hpr-rps.hres.ca/pdl.php?lang=en

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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 …

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

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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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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 ensures that …

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

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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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Search Page - Drug and Health Product Register

(4 days ago) WebReport a serious adverse drug reaction (for hospitals) Report a medical device problem (for health care professionals) Prescription Drug List; About . About the Drug and Health …

https://hpr-rps.hres.ca/

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Health Canada Drug Labelling, NDS & Drug Submissions in 2023

(7 days ago) WebProposed Changes to Labelling of Pharmaceutical Drugs for Human Use: Health Canada launched a consultation on a proposal to amend the labeling of …

https://qualitysmartsolutions.com/news/health-canada-guidance-drug-labelling-nds-rolling-reviews/

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