Health Canada Pdcs Changes

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Notice: Revisions to the performance standards for Post

(9 days ago) WEBOur file number: 22-107706-88. Health Canada is revising the performance standards for Post-authorization Division 1 Changes (PDCs) for prescription pharmaceutical drugs and those administered or obtained through a health professional. The performance …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-revisions-performance-standards-post-authorization-division-1-changes.html

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GUIDANCE DOCUMENT

(1 days ago) WEBHealth Canada Management of Disinfectant Drug Applications Effective Date: 2018/01 1 INTRODUCTION 1.1 Policy Objectives The purpose of this guidance document is to …

https://publications.gc.ca/collections/collection_2018/sc-hc/H13-9-5-2018-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 guidance …

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

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Health Canada updates guidance on switching of a medicinal

(5 days ago) WEBOn April 21, 2022, Health Canada published its revised draft guidance on switching a medicinal ingredient from prescription to a non-prescription status …

https://www.torys.com/en/our-latest-thinking/publications/2022/05/health-canada-updates-guidance-on-switching-of-a-medicinal-ingredient

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Notice: Revision to the Guidance Document Management of Drug

(9 days ago) WEBReflecting the updates made to the performance standards for Post-authorization Division 1 Changes (PDCs) for prescription pharmaceutical drugs and …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-revision-guidance-document-management-drug-submissions-applications-august-2022.html

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Health Canada, CADTH & INESS Collaborate on Aligned Drug …

(1 days ago) WEBThe change is expected to reduce time between Health Canada’s market authorization and HTA recommendations (where possible) by allowing for earlier …

https://www.pdci.ca/health-canada-cadth-iness-collaborate-on-aligned-drug-review-processes/

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Guidance document : post-drug identification number (DIN) …

(1 days ago) WEBPublication information; Department/Agency : Canada. Health Canada, issuing body. Title : Guidance document : post-drug identification number (DIN) changes.

https://publications.gc.ca/site/eng/9.911080/publication.html

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Health Canada Implementation of ICH Q12: CMC Changes

(Just Now) WEBIntroduction of the Level III – Immediate Notification reporting category will allow the notification of changes in a timely manner of the changes that have been …

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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Quality and quantity of data used by Health Canada in approving …

(4 days ago) WEBHealth Canada approved 326 new drugs for 407 indications. The percent of orphan drugs approved increased from 35.6 to 51.3%. The number of indications per …

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10720610/

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Canada Re-Criminalizes Public Drug Use in British Columbia

(5 days ago) WEBThe government of Canada on Tuesday walked back part of a program allowing people in British Columbia to possess small amounts of drugs, including heroin …

https://www.nytimes.com/2024/05/07/world/canada/british-columbia-public-drug-use.html

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Guidance Document

(6 days ago) WEBDate Change Location (Section, paragraph) Nature of and/or Reason for Change November 26, 2020 Changes were made to reflect the new names of the bureaus in the …

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

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These forms of cancer are expected to grow in 2024. Here’s why

(1 days ago) WEB2:56 Health Matters: 247K Canadians expected to get cancer in 2024 The number of cancer cases and deaths in Canada is expected to increase this year because of a …

https://globalnews.ca/news/10487394/cancer-rates-canada-estimates-2024/

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Guidance Document

(2 days ago) WEBless cumbersome on industry and Health Canada. Change 2) January 2, 2019 Some revisions throughout the document Nature of and/or Division 1 Changes for biologics …

https://publications.gc.ca/collections/collection_2022/sc-hc/H164-267-2022-eng.pdf

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Canada's new cancer figures reflect a mixed message: study

(6 days ago) WEBIt also accounted for 25 per cent of deaths in 2022, according to Statistics Canada data. Overall, the researchers projected there will be 247,100 new cancer …

https://www.cbc.ca/news/health/cancer-cmaj-may-1.7200589

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"Spoon Theory" Can Change the Way You View Mental Health

(8 days ago) WEBKey points. Many people can easily go to work, run errands, meet friends, and still have energy left over. People with chronic illnesses, disabilities, or mental health …

https://www.psychologytoday.com/ca/blog/social-instincts/202405/spoon-theory-can-change-the-way-you-view-mental-health

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Submitting pediatric development plans and studies: Guidance

(5 days ago) WEBUnder this policy, Health Canada will be asking sponsors who file a new drug submission (NDS) and certain supplements to a new drug submission (SNDS) to include a pediatric …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/pediatrics/guidance-submitting-development-plans-studies.html

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The giant solar storm is having measurable effects on Earth : NPR

(8 days ago) WEBThe National Oceanic and Atmospheric Administration says there have been measurable effects and impacts from the biggest geomagnetic storm in decades.

https://www.npr.org/2024/05/10/1250515730/solar-storm-geomagnetic-g4

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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 maintain and …

https://publications.gc.ca/collections/collection_2022/sc-hc/H167-2-2021-3-eng.pdf

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Aberrant CHCHD2 -associated mitochondriopathy in Kii ALS/PDC …

(Just Now) WEBAmyotrophic Lateral Sclerosis/Parkinsonism-Dementia Complex (ALS/PDC), a rare and complex neurological disorder, is predominantly observed in the Western …

https://link.springer.com/article/10.1007/s00401-024-02734-w

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Statement from the Minister of Health on the deferral of Coming …

(4 days ago) WEBThese changes aim to protect Canadian consumers from excessive prices for patented medicines by providing the Patented Medicine Prices Review Board with …

https://www.canada.ca/en/health-canada/news/2021/12/statement-from-the-minister-of-health-on-the-deferral-of-coming-into-force-of-the-regulations-amending-the-patented-medicines-regulations.html

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Biologics and Genetic Therapies Directorate

(Just Now) WEBAny questions or comments on this report should be forwarded to: Office of Submissions and Intellectual Property, Resource Management and Operations Directorate Finance …

https://publications.gc.ca/collections/collection_2020/sc-hc/H2-2-2019-3-eng.pdf

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Health Canada to monitor disaggregated data in clinical evidence …

(4 days ago) WEBIn support of Health Canada’s Sex- and Gender-Based Analysis Plus Action Plan, the Health Products and Food Branch is improving capacity to collect the …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/monitor-inclusion-disaggregated-data-clinical-evidence-notice.html

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Forward Regulatory Plan 2022-2024: Regulations Amending the

(2 days ago) WEBHealth Canada will continue to engage stakeholders in 2023-2024. Health Canada published the regulatory amendments to improve the labeling of natural health products …

https://www.canada.ca/en/health-canada/corporate/about-health-canada/legislation-guidelines/acts-regulations/forward-regulatory-plan/plan/self-care-framework.html

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Canadian pediatric development plans: Guidance - Canada.ca

(4 days ago) WEBHealth Canada will conduct the pediatric plan review at the same time as the pre-market review. The service standard for reviewing the C-PDP is the same as the service …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/pediatrics/guidance-submitting-development-plans-studies/canadian.html

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