Health Canada Drug Submissions

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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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Management of Drug Submissions and Applications

(Just Now) WebArchived Versions. Management of Drug Submissions [2019-07-25] Date modified: 2021-05-26. Guidance Documents – Applications and submissions – Drug …

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

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Guidance document : management of drug submissions …

(1 days ago) WebOttawa, ON : Health Canada = Santé Canada, July 2021. ©2021 : Description : 1 online resource (72 pages) ISBN : 9780660393704 : Catalogue number : H164-277/2021E-1 …

https://publications.gc.ca/site/eng/9.901130/publication.html

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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 …

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

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Drug and Health Product Submissions Under Review (SUR)

(2 days ago) WebDrug and Health Product Submissions Under Review (SUR) Drug and Health Product Submissions Under Review (SUR) Present the list of new drug submissions (NDSs) …

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

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Guidance for Industry Preparation of the Quality Information …

(2 days ago) WebTechnical Document‐ Quality Questions and Answers/ Location Issues, as well as the Health Canada Guidance documents for Industry on the preparation of various types of …

https://publications.gc.ca/collections/collection_2019/sc-hc/H164-242-2018-eng.pdf

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Guidance Document

(2 days ago) WebHealth Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613‐957‐2991 Toll free: 1‐866‐225‐0709 Fax: 613‐941‐5366. TTY: 1‐800‐465‐7735. E‐mail: …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-eng.pdf

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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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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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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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Health Canada: Guidance Document Management of Drug …

(9 days ago) WebHealth Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA).This guidance …

https://www.regulatoryaffairsnews.com/post/health-canada-guidance-document-management-of-drug-submissions-and-applications-post-din-changes

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Health Canada Drug Labelling, NDS & Drug Submissions in 2023

(7 days ago) WebHealth Canada regulates the approval and sale of all drugs in Canada. The regulatory framework for new drug submissions is outlined in the Food and Drugs Act …

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

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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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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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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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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) WebSubmissions currently under review: New drug submissions Publisher - Current Organization Name: Health Canada Licence: Open Government Licence - Canada

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

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