Health Canada Drug Product Submission
Listing Websites about Health Canada Drug Product Submission
Health Canada Drug Labelling, NDS & Dr…
(7 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://qualitysmartsolutions.com/news/health-canada-guidance-drug-labelling-nds-rolling-reviews/
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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 …
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Guidance for completing the Drug Submission …
(2 days ago) WebFor instructions on how to file veterinary drug submissions, please e-mail the Submission and Knowledge Management Division at vdd.skmd.so …
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Drugs and health products - Canada.ca
(4 days ago) WebHealth Canada plays an active role in ensuring that you have access to safe and effective drugs and health products. The Department strives to maintain a balance between the …
https://www.canada.ca/en/health-canada/services/drugs-health-products.html
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Guidance document : product monograph. : H164 …
(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 …
(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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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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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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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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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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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 …
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Health Canada's Proposal to Accelerate New Drug Reviews
(3 days ago) WebIntroduction. To obtain authorization to market a new active substance (NAS, a molecule never marketed before in Canada in any form), companies typically file a new drug …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294445/
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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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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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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 submissions ontario.ca
(4 days ago) WebContact us. Inquiries regarding drug submissions should be directed to: 5700 Yonge Street, 3 rd Floor Toronto, Ontario M2M 4K5 Tel: 416-327-8099 Fax: 416-327-8123 …
https://www.ontario.ca/page/drug-submissions
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New drug submissions in Canada and a comparison with the Food …
(3 days ago) WebBackground Health Canada posts the outcomes of all New Drug Submissions. In some cases, companies have withdrawn submissions or …
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0286802
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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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Health Canada updates guidance on nitrosamine impurities in …
(4 days ago) WebDrug Establishment Licensing Bulletin 176, April 30, 2024. Health Canada has updated the Guidance on nitrosamine impurities in medications. Updates to general and …
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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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Notice: Multiple Additions to the Prescription Drug List - canada.ca
(7 days ago) WebShould you have any questions regarding this notice, please contact: Health Canada. Pharmaceutical Drugs Directorate. Bureau of Policy, Science and International …
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Health Product InfoWatch: April 2024 - Canada.ca
(7 days ago) Web1. Sulfatrim, Sulfatrim DS, Sulfatrim Pediatric (sulfamethoxazole and trimethoprim tablets USP) [product monograph]. Vaughan (ON): AA Pharma Inc.; 2023. …
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