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Guidance Document: The Management of Drug Submissions and …

(8 days ago) 1.1 Purpose/overviewThe Guidance Document: Management of Drug Submissions and Applications (MSDA) gives sponsors and Health Canada staf… See more

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 Post-Drug Identification Number (DIN) …

(2 days ago) WebAs per Part C, Section C.01.014.4 of the Regulations, Health Canada must be notified whenever there is a change in "the subject matter of the information" …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-drug-identification-number-changes.html

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Guidance Document: The Management of Drug Submissions and …

(9 days ago) Web2005 Health Canada guidance document providing clarification of the way in which Health Canada manages information and material submitted by sponsors in accordance with …

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

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Post-Drug Identification Number (DIN) Changes Guidance …

(Just Now) WebFrom Health Canada. Overview All drugs subject to the Food and Drug Regulations are required to gain premarket authorization prior to issuance of a Drug Identification …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/post-drug-identification-number-changes-profile.html

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Guidance Document

(2 days ago) WebH164-267/2022E-PDF ISBN: 978-0-660-41474-4 Pub.: 210495 . Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly …

https://publications.gc.ca/collections/collection_2022/sc-hc/H164-267-2022-eng.pdf

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GUIDANCE DOCUMENT

(1 days ago) WebHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality Cat.: H13-9/5-2018E-PDF ISBN: 978-0-660-24805-9 Pub.: …

https://publications.gc.ca/collections/collection_2018/sc-hc/H13-9-5-2018-eng.pdf

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Questions and Answers: Plain Language Labelling Regulations

(9 days ago) WebFor NC or PDC submissions, Health Canada will accept annotated written text, in lieu of mock-ups, to reflect proposed changes to the inner/outer labels. (e.g., …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/questions-answers-plain-language-labelling-2019/document.html

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Guidance Document: Questions and Answers: Plain …

(2 days ago) WebDraft text labels can be submitted using any software (e.g., word, pdf, etc.) at the discretion of the sponsor and should include font type, font size, headings, line width, etc. (i.e., CDFT format) including …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/questions-answers-plain-language-labelling-non-prescription-drugs-2019/document.html

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Submitting pediatric development plans and studies: Guidance

(5 days ago) WebDownload in PDF format (712 KB, 32 pages) Organization: Health Canada. Date published: May 2024. Cat.: H164-362/2024E-PDF ISBN: 978-0-660-71517-9 Pub.: 240083. On this …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/pediatrics/guidance-submitting-development-plans-studies.html

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Therapeutic Products Directorate

(2 days ago) WebHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of …

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

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Guidance Document - Canada.ca

(8 days ago) WebCat.: H164-277/2022E-PDF ISBN: 978-0-660-44261-7 Pub.: 220295. Division 1 Change (PDC-prescription) for prescription pharmaceuticals and those administered or obtained …

https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/management-drug-submissions/industry/guidance-document-management-drug-submissions-applications.pdf

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Drug Product Database: Access the database - Canada.ca

(Just Now) WebSearch the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. The DPD is updated nightly and includes: availability of the drug in …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

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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 provides …

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

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Canadian pediatric development plans: Guidance - Canada.ca

(4 days ago) WebHealth Canada will conduct the pediatric plan review at the same time as the pre-market review. The service standard for reviewing the C-PDP is the same as the service …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/pediatrics/guidance-submitting-development-plans-studies/canadian.html

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Biologics and Genetic Therapies Directorate

(Just Now) WebHealth Canada is the federal department responsible for helping the people of Canada maintain and improve their health. Health Canada is committed to improving the lives of …

https://publications.gc.ca/collections/collection_2020/sc-hc/H2-2-2019-3-eng.pdf

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Health Canada data strategy. : H14-336/2019E-PDF

(1 days ago) WebView H14-336-2019-eng.pdf (PDF, 3.53 MB). Note(s) Issued also in French under title: Stratégie de données de Santé Canada. "Pub.: 190327." Includes bibliographical …

https://publications.gc.ca/site/eng/9.878872/publication.html

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Canada - World Health Organization

(7 days ago) WebCanada Health system review Gregory P. Marchildon Sara Allin Sherry Merkur The North American Observatory on Health Systems and Policies (NAO) is a collaborative …

https://apps.who.int/iris/bitstream/handle/10665/336311/HiT-22-3-2020-eng.pdf

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Health at a Glance 2023: Highlights for Canada - oecd.org

(Just Now) WebCanada perfoms better than the OECD average on 63% of indicators (Based on 27 indicators, data missing for 6 indicators) Canada perfoms better than the OECD average …

https://www.oecd.org/canada/health-at-a-glance-Canada-EN.pdf

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Peptide-drug conjugates: A new paradigm for targeted cancer …

(1 days ago) WebPeptide-drug conjugates (PDCs) are the new hope for targeted therapy after antibody-drug conjugates (ADCs). Compared with ADCs, the core advantages of PDCs …

https://www.sciencedirect.com/science/article/abs/pii/S0223523423010863

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Public health communication professional development

(7 days ago) WebHighlights. There have been widespread calls to transform the public health workforce in Canada. We conducted an environmental scan and content analysis to determine …

https://www.canada.ca/en/public-health/services/reports-publications/health-promotion-chronic-disease-prevention-canada-research-policy-practice/vol-44-no-5-2024/public-health-communication-professional-development-opportunities-core-competencies-environmental-scan-content-analysis.html

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Guidance Document

(6 days ago) WebHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …

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

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Other Public Health Agency of Canada publications, HPCDP: Vol …

(Just Now) WebDownload in PDF format (446 kB, 1 page) Published by: The Public Health Agency of Canada Date published: May 2024 ISSN: 2368-738X. Subscribe to HPCDP. Submit a …

https://www.canada.ca/en/public-health/services/reports-publications/health-promotion-chronic-disease-prevention-canada-research-policy-practice/vol-44-no-5-2024/other-phac-publications.html

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Guidance Document: Questions and Answers: Plain Language

(5 days ago) WebThis document provides information for industry on how Health Canada's Health Products and Food Branch interprets and applies the 2014 Regulations …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/guidance-document-questions-answers-plain-language-labelling-regulations-non-prescription-drugs-contact-lens-disinfectants.html

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