Health Canada Variation Guidelines

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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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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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Approach for Post-Approval Changes - PQRI

(1 days ago) WebChange Description Health Canada US FDA Deleting an analytical procedure that has been demonstrated to be redundant with respect to the remaining analytical procedures (e.g., …

https://pqri.org/wp-content/uploads/2015/08/pdf/krishnan..pdf

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Guidance document : post-notice of compliance (NOC) changes : …

(1 days ago) WebCanada. Health Canada, issuing body. Title : Guidance document : post-notice of compliance (NOC) changes : safety and efficacy document (for pharmaceutical, biologic …

https://publications.gc.ca/site/eng/9.880801/publication.html

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Guidance Document

(2 days ago) WebHealth Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented. Post-Notice of Compliance (NOC) Changes: …

https://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-31-2019-eng.pdf

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COVID-19 epidemiology update: Testing and variants — Canada.ca

(4 days ago) WebTesting in Canada for COVID-19. On December 5, 2022, we changed surveillance systems for monitoring laboratory testing of SARS-CoV-2, the virus that causes COVID-19. We …

https://health-infobase.canada.ca/covid-19/testing-variants.html

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Health Canada Implementation of ICH Q12: CMC Changes

(Just Now) WebHealth Canada is partially aligned • Concept is well understood –we have our CPID (Certified Product Information Document) • Concept of PLCM has been introduced …

https://www.casss.org/docs/default-source/cmc-strategy-forum-north-america/2021-cmc-na-speaker-presentations/hamel-hugo-health-canada-2021.pdf?sfvrsn=9db6e87d_8

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Health Canada on Significant Changes: Guidance for …

(8 days ago) WebAug 4, 2021. Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to significant changes to medical devices …

https://www.regdesk.co/health-canada-on-significant-changes-guidance-for-implementation/

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Overview of Post Approval Changes Requirements for Active

(8 days ago) WebCANADA Health Canada is a regulatory authority of Canada. It has provided guidelines related to post-approval changes under the title “Post‐Notice of Compliance (NOC) …

https://pdfs.semanticscholar.org/58e3/980ca06e1b17d0cafe8506f1b130729aa5de.pdf

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Canada hesitates to update public health guidelines on risk from

(3 days ago) WebThe rapid spread of more contagious coronavirus variants across Canada has led some hard-hit regions to question whether national public health guidelines go far …

https://www.cbc.ca/news/health/coronavirus-variants-canada-risk-1.5901797

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Changes to the Manufacturer's name and/or Product Name - CAPRA

(2 days ago) WebThe Policy on Changes in Manufacturer’s name and/or Product Name (CMPN) applies to drug submissions to Health Canada where the manufacturer's and/or …

https://capra.ca/en/blog/changes-to-the-manufacturers-name-andor-product-name-2017-09-05.htm

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Canadian Cardiovascular Harmonized National Guideline …

(4 days ago) Webmany guidelines at the same time; and that at least in the past, some of the recommendations were not harmonized and seemed contradictory.1 Established in 2008 …

https://www.cmaj.ca/content/cmaj/194/43/E1460.full.pdf

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Specifications: Test Procedures and Acceptance Criteria for

(4 days ago) WebHealth Canada is pleased to announce the adoption of the ICH guidance document Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/international-conference-harmonisation/quality/specifications-test-procedures-acceptance-criteria-new-drug-substances-new-drug-products-chemical-substances-topic.html

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Cleaning validation guide. : H139-6/2021E-PDF - Government of …

(1 days ago) WebIt provides guidance on cleaning validation. It will help you understand and comply with Part C, Division 2 of the Food and Drug Regulations (the Regulations)"--page 6. Canada. …

https://publications.gc.ca/site/eng/9.882942/publication.html

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Canadian Cardiovascular Harmonized National Guideline …

(1 days ago) WebCanadian Cardiovascular Harmonized National Guideline Endeavour (C-CHANGE) guideline for the prevention and management of cardiovascular disease in …

https://pubmed.ncbi.nlm.nih.gov/36343954/

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Draft Guidance Document: Quality (Chemistry and …

(9 days ago) Webmaintain and improve their health. Health Canada The Health Products and Food Branch’s mandate is to take an integrated approach to the management of the risks and benefits …

https://www.fdanews.com/ext/resources/files/01/01-27-14-CanadaDraftGuidance.pdf

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