Health Canada Guidance Document

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Guidance documents – Medical devices - Canada.ca

(3 days ago) WEBGuidance documents have been prepared to assist in the interpretation of policies and governing statutes and regulations. They are intended to assist in preparing …

https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents.html

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Guidelines - Canada.ca

(7 days ago) WEBGuidelines. Guidelines (sometimes called guidance documents or directives) are important administrative documents that support laws and regulations. Unlike laws and …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/guidelines.html

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Guidance Document: The Management of Drug Submissions and …

(8 days ago) WEBGuidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. …

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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Organization and document placement for Canadian module 1

(2 days ago) WEBHealth Canada has updated the organization and document placement for Canadian module 1 to reflect recent changes. This document contains a table outlining …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/organization-document-placement-canadian-module-1.html

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Guidance Document: Quality (Chemistry and Manufacturing

(3 days ago) WEBThis Health Canada guidance document follows the format recommended in ICH's CTD-Q guideline. The text following each section title is taken directly from the …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/chemical-entity-products-quality/guidance-document-quality-chemistry-manufacturing-guidance-new-drug-submissions-ndss-abbreviated-new-drug-submissions.html

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Good manufacturing practices guide for drug products …

(4 days ago) WEBValidate cleaning procedures for manufacturing equipment based on Health Canada’s Cleaning Validation Guide (GUI-0028). This guide also provides guidance for establishing acceptable product residue limits. Ensure …

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-manufacturing-practices/guidance-documents/gmp-guidelines-0001/document.html

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Guidance document: Product Monograph (2020) - Canada.ca

(1 days ago) WEB1.1 Purpose. The purpose of this guidance document is to assist sponsors in developing product monographs with acceptable format and content. Health Canada …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/product-monograph/guidance-document-product-monograph-2020.html

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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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Guidance on clinical evidence requirements for medical devices

(4 days ago) WEBGuidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide assistance to staff …

https://publications.gc.ca/collections/collection_2023/sc-hc/H164-347-1-2023-eng.pdf

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Guidance on how to complete the application for a new …

(2 days ago) WEBGuidance documents provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. They also provide guidance to …

https://publications.gc.ca/collections/collection_2021/sc-hc/H164-315-2021-eng.pdf

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Reducing COVID-19 risk in community settings: A tool for …

(3 days ago) WEB2022-12-06. This tool is a resource for operators of non-health care community settings the public can access. This tool is based on available guidance about individual and …

https://health.canada.ca/en/public-health/services/diseases/2019-novel-coronavirus-infection/guidance-documents/reducing-covid-19-risk-community-settings-tool-operators.html

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Guidance Document

(2 days ago) WEBCSP Guidance Document 2 Health Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are …

https://publications.gc.ca/collections/collection_2023/sc-hc/H164-305-2023-eng.pdf

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Guidance Document

(2 days ago) WEBChanges: Safety and Efficacy Document. Date Adopted: 2009/09/02 Revised Date: 2019/08/12. Effective Date: 2019/08/12. Health Canada is responsible for helping …

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 releases new guidance document on clinical …

(6 days ago) WEBOn November 15, 2022, Health Canada released a new guidance document, “ Guidance on clinical evidence requirements for medical devices .”. In this …

https://www.smartbiggar.ca/insights/publication/health-canada-releases-new-guidance-document-on-clinical-evidence-requirements-for-medical-devices

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Health Canada Draft Revised Guidance Documents on Post-NOC

(7 days ago) WEBOn August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder …

https://capra.ca/en/blog/health-canada-draft-revised-guidance-documents-on-post-noc-changes-quality-for-consultation-2021-09-30

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Guidance for the response and management of a poliovirus event …

(Just Now) WEBThe Public Health Agency of Canada would like to express sincere gratitude to all individuals and organizations who contributed to the development of the Guidance …

https://www.canada.ca/en/services/health/publications/diseases-conditions/guidance-response-management-poliovirus-event-outbreak-canada.html

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Guidance Document

(6 days ago) WEBGuidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance …

https://www.publications.gc.ca/collections/collection_2020/sc-hc/H13-9-25-2020-eng.pdf

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Health Canada – Final version of GUI-0100 now available

(6 days ago) WEBThe content of Guidance for Records Related to Clinical Trials (GUI-0068, May 2006) published by Health Canada, which is replaced by GUI-0100. Frequently asked …

https://www.ctg.queensu.ca/bulletin/health-canada-%E2%80%93-final-version-gui-0100-now-available

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Guidance Document

(6 days ago) WEBGuidance documents are meant to provide assistance to industry and health care professionals on how to comply with governing statutes and regulations. Guidance …

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

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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 …

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

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Guidance Documents (National and International) IPAC Canada

(9 days ago) WEBCoronavirus (COVID-19) National and International Guidance Documents. Public Health Agency of Canada CORONAVIRUS HOTLINE 1-833-784-4397. …

https://ipac-canada.org/guidance-documents-national-and-international

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