Health Canada Variation Guidance

Listing Websites about Health Canada Variation Guidance

COVID-19 variants of concern

(3 days ago) WebMost notably the following have been detected in Canada and are considered variants of concern: Alpha (B.1.1.7) Beta (B.1.351) Gamma (P.1) Delta (B.1.617) Omicron …

https://sac-isc.gc.ca/eng/1615991390358/1615991423624

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COVID-19 epidemiology update: Testing and variants — …

(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 …

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

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

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

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

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Best Practices for the Development, Scale-up, and Post …

(3 days ago) WebWhere there are differences between Health Canada data requirements to support pre- and post-NOC changes, In 2003 , the Variations Guidance was …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4037495/

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Canada hesitates to update public health guidelines on risk from

(3 days ago) WebBut I think the science has evolved, or at least our thinking has evolved." Canada quietly updates COVID-19 guidelines on risk of airborne spread. PHAC was …

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

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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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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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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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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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Post-approval Changes – Stability Requirements and Regulations

(1 days ago) WebWHO (February 2007) Annex 6 variations guidance: guidance on variations to a prequalified product dossier. Google Scholar Health Canada (February 2007) Draft …

https://link.springer.com/chapter/10.1007/978-0-387-85627-8_5

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Post-NOC Changes – Quality Guidance Overview and Update

(3 days ago) WebRelaxation of an acceptance criteria (Cont’d) Principal Supporting Data Requirements: Updated specification with justification for the change. If a Schedule B standard is …

https://capra.ca/_uploads/58824e351b51c.pdf

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Guidance Document

(2 days ago) Webguidance posted on the Health Canada website. Updates to this guidance reflect a modification of the reporting category for safety changes from a Notifiable Change to a …

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

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Health Canada on Significant Changes: Guidance for Implementation

(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 …

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

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Health Canada Regulatory Modernization: Yesterday, Today …

(9 days ago) Web2 Overview In 2017, Health Canada started a five-year initiative on improving regulatory review of drugs and devices (R2D2)1.The goal of this initiative was to develop an agile …

https://www.certara.com/app/uploads/2021/03/WP_Health_Canada_Regulatory_Modernization.pdf

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ISPE Team Assists Health Canada with Training on ICH Q12 …

(4 days ago) WebISPE’s Q12 Implementation Team. ISPE’s PQLI® initiative was created to provide guidance on practical implementation of the concepts described in ICH …

https://ispe.org/pharmaceutical-engineering/ispeak/ispe-team-assists-health-canada-training-ich-q12-implementation

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