Health Canada Submission Management
Listing Websites about Health Canada Submission Management
Guidance Document: The Management of Drug …
(8 days ago) This guidance document applies to all drug submission/application typesFootnote 1including: 1. Clinical Trial Application (CTA), Clinical Trial Application - Amendment (CTA-A)Footnote 2 2. New Drug Submission (NDS) 3. Supplement to a New Drug … See more
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Guidance Document: The Management of Drug …
(9 days ago) WEBTelephone: 613-957-0368. Fax: 613-952-7756. Teletypewriter: 1-800-465-7735 (Service Canada) E-mail: pharma_drug_enquiries-renseignements_medicaments_pharma@hc …
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Drug and Health Product Submissions Under Review …
(3 days ago) WEBThe Submissions Under Review (SUR) Lists include new drug submissions containing new active substances (pharmaceuticals and biologics with an active ingredient not …
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Guidance document : management of drug submissions …
(1 days ago) WEBOttawa, ON : Health Canada = Santé Canada, July 2021. ©2021 : Description : 1 online resource (72 pages) ISBN : 9780660393704 : Catalogue number : H164-277/2021E-1 …
https://publications.gc.ca/site/eng/9.901130/publication.html
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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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Guidance Document
(6 days ago) WEBAdministrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs 2 Health Canada is responsible for helping Canadians maintain and …
https://www.publications.gc.ca/collections/collection_2020/sc-hc/H13-9-25-2020-eng.pdf
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Health Canada updates Guidance Document: The …
(9 days ago) WEBSeptember 30, 2019. On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of Drug Submissions and Applications. The …
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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 …
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Therapeutic Products Directorate
(2 days ago) WEBDrug Submission Performance Quarterly Report October - December 2021. Health Canada is the federal department responsible for helping the people of Canada …
https://publications.gc.ca/collections/collection_2022/sc-hc/H167-2-2021-3-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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Regulatory submissions and transactions with Health Canada
(8 days ago) WEBStarting January 1, 2020, all regulatory transactions for Master Files prepared in the non-eCTD format must be sent via the Common Electronic Submission …
https://www.certara.com/blog/regulatory-submissions-and-transactions-with-health-canada/
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Management of Drug Submissions - FDAnews
(6 days ago) WEBHealth Canada Management of Drug Submissions Guidance for Industry 2 Does not apply to combinations of drugs and medical devices where the two drug components …
https://www.fdanews.com/ext/resources/files/01/01-13-CanadianSubmissions.pdf
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Health Canada's Proposal to Accelerate New Drug Reviews
(3 days ago) WEBWhen received, it is expected that the submission will contain the information and material for the purposes of Division 8, Part C of the Food and Drug Regulations and be subject …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294445/
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Health Canada Implementation of ICH Q12: CMC Changes
(Just Now) WEB– Health Canada recommends that the PLCM document be provided in tabular format in eCTD section 3.2.R.8, with specific references to the submission …
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Strategies for Filing Efficient Submissions - CAPRA
(3 days ago) WEBThe Cover Letter should clearly indicate the reason for the filing and relevant pre-submission correspondence with Health Canada should be referenced (as well as …
https://capra.ca/_uploads/5dd407959141a.pdf
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The Drug Review and Approval Process in Canada – An eGuide
(Just Now) WEBIn addition, Life Cycle Management activities (post approval submissions to Health Canada, for new indications, new dosage forms, new strengths, manufacturing changes, …
https://spharm-inc.com/the-drug-review-and-approval-process-in-canada-an-eguide/
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Health Canada Drug Labelling, NDS & Drug Submissions in 2023
(7 days ago) WEBProposed Changes to Labelling of Pharmaceutical Drugs for Human Use: Health Canada launched a consultation on a proposal to amend the labeling of …
https://qualitysmartsolutions.com/news/health-canada-guidance-drug-labelling-nds-rolling-reviews/
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Guidance document : preparation of regulatory activities in the
(1 days ago) WEBGuidance document : preparation of regulatory activities in the Electronic Common Technical Document (eCTD) format.: H164-293/2019E-PDF "This guidance document …
https://publications.gc.ca/site/eng/9.882674/publication.html
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Guidance Document
(6 days ago) WEBManagement of Drug Submissions and Applications Date Adopted: November 26, 2020 Revised Posted: 2021/05/21 Effective Date: 2021/05/21 . Guidance Document: …
https://www.publications.gc.ca/collections/collection_2021/sc-hc/H164-277-2021-eng.pdf
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Submission for Review: Revision and Consolidation of Two Existing
(3 days ago) WEBThe Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a revised information collection …
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