Health Canada Quality Guidance
Listing Websites about Health Canada Quality Guidance
Guidance Document: Quality (Chemistry and Manufacturing
(3 days ago) S.4.1 SpecificationThe specification for the drug substance should be provided. As defined in ICH's Q6A guidance document, a specification is a list … See more
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Publication of the Health Canada Guidance Document: Quality …
(2 days ago) WEBSignificant new requirements are presented in the guidance document (i.e. stability studies on three batches of product for existing drugs, commercial scale batches …
https://open.canada.ca/data/en/info/89e44fc0-5ead-423b-a518-b6bf2e604c02
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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 health services are accessible, and works to reduce health …
https://publications.gc.ca/collections/collection_2018/sc-hc/H13-9-8-2018-eng.pdf
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Guidance Document - Quality (Chemistry and Manufacturing) …
(5 days ago) WEBGuidance Document - Quality (Chemistry and Manufacturing) Guidance: Clinical Trial Applications (CTAs) for Pharmaceuticals (CTAs) filed with Health Canada by …
https://open.canada.ca/data/en/dataset/ea7ff183-a4a0-4961-b283-a382559a00aa
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Guidance Document
(2 days ago) WEBensures that high-quality health services are accessible, and works to reduce health risks. Également disponible en français sous le titre : guidance posted on the Health …
https://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-31-2019-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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Guidance Document - Quality (Chemistry and Manufacturing) …
(8 days ago) WEBTo assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical …
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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 …
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Health Canada publishes final guidance documents on quality
(3 days ago) WEBOn October 30, 2017, Health Canada published the final version of the following guidance documents and template. Open search. Close search. The changes will be …
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Post-Notice of Compliance (NOC) Changes – Quality Guidance
(5 days ago) WEBThis guidance document applies to sponsors intending to make changes to new drugs that have received a NOC pursuant to Section C.08.004 of the Food and Drug Regulations. …
https://open.canada.ca/data/en/dataset/f5e9bc41-83a9-44b2-9bcc-4be7e12d61f4
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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 …
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Current state of Health Canada regulation for cellular and gene …
(7 days ago) WEBIn developing new guidance documents, Health Canada consults existing quality and pre-clinical/clinical drug product development guidance documents from …
https://www.sciencedirect.com/science/article/pii/S1465324919300416
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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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Health Canada Incorporates QbD in Updated Quality Guidance
(8 days ago) WEBHealth Canada Jan. 24 issued draft guidance updating the quality information drugmakers must submit. Among the changes is guidance on how to …
https://www.fdanews.com/articles/162108-health-canada-incorporates-qbd-in-updated-quality-guidance
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Guidance for Evaluating Human Health Effects in Impact …
(3 days ago) WEBHealth Canada. 2023. Guidance for Evaluating Human Health Effects in Impact Assessment: AIR QUALITY. Healthy Environments and Consumer Safety Branch, …
https://publications.gc.ca/collections/collection_2024/sc-hc/H129-54-1-2023-eng.pdf
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