Health Canada Drug Product Submission

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Drug and Health Product Submissions Under Review (SUR)

(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 Submissions and …

(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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Guidance document : product monograph. : H164-299/2020E-PDF

(1 days ago) WEBHealth Canada reviews the product monograph as part of the drug review process, as it forms an integral part of a new drug submission. A product monograph is intended to …

https://publications.gc.ca/site/eng/9.890868/publication.html

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Guidance document : management of drug submissions and …

(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 …

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

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Product Monograph

(2 days ago) WEBAbbreviated New Drug Submission (ANDS) or Supplement to an Abbreviated New Drug Submission (SANDS) is filed for either a prescription or nonprescription drug. Health …

https://publications.gc.ca/collections/collection_2020/sc-hc/H164-299-2020-eng.pdf

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Guidance for Industry Preparation of the Quality Information …

(2 days ago) WEBrequested to submit test protocols and drug product consistency samples and/or material 2.4 Other information Should is changed to may 2018‐07‐09 (See also, the Health …

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

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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 …

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

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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 …

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

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Drug and Health Products Portal

(7 days ago) WEBDrug and Health Product Portal. Follow: Drugs Natural Health Products Medical Devices Vet Drugs. Enter search term (s) Report a problem or mistake on this page. Share this …

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

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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 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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About the Drug and Health Product Register and Portal

(6 days ago) WEBThe first release of the Drug and Health Product Register (DHPR) took place in winter 2015. The DHPR is evolving and will soon become the Drug and Health Product Portal …

https://dhpp.hpfb-dgpsa.ca/about-drug-and-health-product-register-and-portal

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Ontario Guidelines for Single Source Drug Products

(1 days ago) WEBDrug costs must exclude upcharge (mark-up) and dispensing fee. The expenditures must be projected for three consecutive twelve-month periods irrespective of the anticipated …

https://www.ontario.ca/files/2024-03/moh-drug-submission-ontario-guidelines-single-source-drug-products-en-2024-03-20.pdf

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Register Of Innovative Drugs Products for Human Use - Active …

(8 days ago) WEB265785 Senvelgo Boehringer Ingelheim Animal Health Canada Inc. N/A 2023-11-28 2029-11-28 2031-11-28 *The medicinal ingredient not previously approved in a drug by the …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/register-innovative-drugs/reg-innov-dr-eng-10-may-2024.pdf

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Search Page - Drug and Health Product Register

(4 days ago) WEBSubmit a report . Report a side effect; Report a serious adverse drug reaction (for hospitals) Report a medical device problem (for health care professionals) Prescription …

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

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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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Unauthorized UMARY Hyaluronic Acid Dietary Supplement …

(6 days ago) WEBDiclofenac for oral consumption is a prescription non-steroidal anti-inflammatory drug (NSAID) used to relieve pain and swelling caused by arthritis. It should be used …

https://recalls-rappels.canada.ca/en/alert-recall/unauthorized-umary-hyaluronic-acid-dietary-supplement-contains-undeclared-prescription

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Eisai starts rolling submission for injectable version of Alzheimer's

(Just Now) WEBEisai and partner Biogen said on Tuesday that the Japanese drugmaker has begun submitting data on a rolling basis to the US health regulator for a marketing …

https://www.reuters.com/business/healthcare-pharmaceuticals/eisai-starts-rolling-submission-injectable-version-alzheimers-drug-with-us-fda-2024-05-14/

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

(2 days ago) WEBPublisher - Current Organization Name: Health Canada Licence: Open Government Licence - Canada; Data and Resources drug-and-health product …

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

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Health Canada Directive

(6 days ago) WEBHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality Cellular and Tissue-Based Products Department of …

https://www.canada.ca/content/dam/hc-sc/documents/services/publications/drugs-health-products/technical-directive-sperm-ova-donors/technical-directive-sperm-ova-donors-2024.pdf

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TikTok Influencer Arrested for Allegedly Selling Fake Ozempic

(4 days ago) WEBA New York TikTok influencer is being charged with illegally dispensing misbranded Ozempic and other weight loss medications through social media.; Buyers …

https://www.healthline.com/health-news/tiktok-influencer-sold-fake-ozempic

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