Health Products Canada Clinical Trials

Listing Websites about Health Products Canada Clinical Trials

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Guidance on the registration of clinical trials and public disclosure

(9 days ago) People also askWhat is Health Canada's clinical trials database?Health Canada, through its Clinical Trials Database, is providing to the public a listing of specific information relating to phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs.Health Canada's Clinical Trials Database - Canada.cacanada.caWhat types of clinical trials are authorized by Health Canada?Health Canada authorizes clinical trials involving healthy volunteers, such as bioavailability or bioequivalence trials, first-in-human trials (that is, when a new drug is administered for the first time in humans), pharmacokinetic studies, drug-drug interaction studies, etc.; however, information about these trials is not included in the database.Health Canada's Clinical Trials Database - Canada.cacanada.caWhat are good clinical practices in Canada?Clinical trials in Canada are required to be conducted under good clinical practices (GCP). GCP includes review and approval of the trial protocol by a Research Ethics Board, and appropriate Informed Consent of clinical trial subjects.Health Canada's Clinical Trials Database Frequently Asked Questionscanada.caDoes Health Canada provide additional information about a clinical trial?Health Canada is providing only the information in the database, and will not make additional information available at this time. For any other information, patients should speak with their physician, and the clinical trial sponsor should be contacted directly.Health Canada's Clinical Trials Database Frequently Asked Questionscanada.caFeedbackCanada.cahttps://www.canada.ca/en/health-canada/services/Health Canada's Clinical Trials DatabaseWebThe database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. Access …

https://www.canada.ca/en/health-canada/programs/consultation-registration-clinical-trials-public-disclosure-results-new-guidance-public-search-portal/overview.html#:~:text=Health%20Canada%20is%20the%20federal%20regulator%20responsible%20for,2%20medical%20devices%203%20natural%20health%20products%20%28NHPs%29

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Health Canada's Clinical Trials Database Frequently Asked …

(4 days ago) WebIf you have concerns about how a clinical trial is being carried out, you may contact the Research Ethics Board that approved the clinical trial (contact information should be …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database/frequently-asked-questions.html

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Clinical Trials - Canada.ca

(8 days ago) WebClinical Trials Manual. ICH Guidances. Guidance for Clinical Trial Sponsors: Clinical Trial Applications [2013-06-21] The Common Technical Document - ICH Topic M4 [2003-06 …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials.html

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Health Canada’s Proposal for Clinical Trials Regulatory - CAPRA

(4 days ago) WebOn May 20, 2021 Health Canada opened a consultation on its proposal to modernize the regulatory framework for clinical trials related to human drugs, medical devices, non …

https://capra.ca/en/blog/health-canadas-proposal-for-clinical-trials-regulatory-modernization-2021-07-16

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What are clinical trials? - CIHR - Canadian Institutes of …

(6 days ago) WebA clinical trial is a research study involving human participants that evaluates the safety and/or effects of one or more interventions on health outcomes. Interventions include, …

https://cihr-irsc.gc.ca/e/52988.html

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Clinical Trials Database (CTD) - Open Government Portal

(5 days ago) WebHealth Canada's Clinical Trials Database is a listing of information about phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a …

https://open.canada.ca/data/en/dataset/d6fe4b32-2eaf-4ac0-9e35-b3841f25e3a7

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What We Heard Report: Future of Clinical Trials - CIHR

(6 days ago) WebThe Canadian Institutes of Health Research (CIHR) is committed to strengthening the clinical trials ecosystem to improve health care and health outcomes for all Canadians. …

https://cihr-irsc.gc.ca/e/53429.html

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CLINICAL TRIALS HANDBOOK - Baker McKenzie

(5 days ago) WebIn Canada, a clinical trial for a drug product (CT) comprises an investigation for use in humans that is intended to 7 Clinical trials for natural health products are governed …

https://www.bakermckenzie.com/-/media/files/insight/publications/2019/healthcare/america/dsc125067_clinical-trials-handbook--canada.pdf

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Health Canada’s Clinical Trial Framework: Stakeholders BLG

(Just Now) WebHealth Canada is proposing a single clinical trial framework for drugs, medical devices, and natural health products (NHPs) as the foundation for the new regulatory regime, …

https://www.blg.com/en/insights/2021/06/health-canadas-modernized-clinical-trial-framework

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Clinical Research Regulation For Canada and United States ClinRegs

(9 days ago) WebHealth Canada. As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, Health Canada (HC) is the competent authority responsible for clinical trial …

https://clinregs.niaid.nih.gov/country/canada/united-states

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Canada Gazette, Part 2, Volume 156, Number 5: Clinical Trials for

(5 days ago) WebThe previous records retention period of 25 years for clinical trials of drugs and natural health products prescribed by the FDR and NHPR created undue regulatory burden on …

https://www.gazette.gc.ca/rp-pr/p2/2022/2022-03-02/html/sor-dors18-eng.html

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Clinical Research Regulation For Canada ClinRegs

(5 days ago) WebHealth Canada. As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, Health Canada (HC) is the competent authority responsible for clinical trial …

https://clinregs.niaid.nih.gov/country/canada

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Health Canada to modernise its clinical trial regulations

(5 days ago) WebFigure 1: The regulatory foundation for the future of clinical trials in Canada is based on a single framework for all health products. The new regulatory regime would enable …

https://www.europeanpharmaceuticalreview.com/news/156664/health-canada-to-modernise-its-clinical-trial-regulations/

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CLINICAL TRIALS IN CANADA - Innovative Medicines Canada

(4 days ago) WebThe innovative pharmaceutical industry has sponsored over two-thirds of clinical trials initiated in Canada in the last 5 years and contributed over $15 billion to the Canadian …

https://innovativemedicines.ca/wp-content/uploads/2023/05/6354_IMC_ResearchNote_ClinicalTrialsCanada_2023_v3-1.pdf

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Clinical trials or studies involving a drug, medical device, or natural

(Just Now) WebHealth Canada's role is with respect to (i) the approval of the drug and related clinical trial or issuing a "No Objection Letter" for a medical device Class II or higher and (ii) …

https://uwaterloo.ca/research/office-research-ethics/research-human-participants/application-process/clinical-trials-or-studies-involving-drug-medical-device-or

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Management of clinical trials during the COVID-19 pandemic: …

(5 days ago) WebGuidance documents for management of drugs for clinical trials involving human subjects. The sponsor must ensure that the clinical trial is conducted in accordance with the …

https://open.canada.ca/data/en/dataset/2531e080-bf87-4ef5-a1fd-2ad345bec22b

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Clinical Trials Nutrasource

(3 days ago) WebBring your innovations to life and access the lucrative health products market through clinical research. At SGS Nutrasource, we bridge the gap between pharmaceutical …

https://www.nutrasource.ca/solutions/clinical-trials/

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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 drug decreased ( …

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

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Health Canada approves Apretude, the first long-acting injectable …

(5 days ago) WebApretude proved superior to daily oral HIV prevention and was generally well tolerated in trials; A long-acting injectable formulation of the HIV drug cabotegravir has been …

https://www.catie.ca/catie-news/health-canada-approves-apretude-the-first-long-acting-injectable-for-hiv-prevention

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Government of Canada funds new projects to further grow the …

(9 days ago) WebThis fund is administered by the Canada Foundation for Innovation. Clinical Trials Fund: Led by CIHR, the Clinical Trials Fund has supported the establishment of a clinical …

https://www.canada.ca/en/research-chairs/news/2024/05/government-of-canada-funds-new-projects-to-further-grow-the-domestic-biomanufacturing-and-life-sciences-sector.html

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MAPS psychedelics research for MDMA therapy comes under …

(4 days ago) WebLykos sponsored the clinical trials of MDMA. The results are included in the company's application to the FDA seeking approval to market the drug for therapy-assisted PTSD …

https://www.npr.org/sections/health-shots/2024/05/13/1250580932/ecstasy-mdma-ptsd-fda-approval

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Wegovy users keep weight off for four years, Novo Nordisk study …

(5 days ago) WebThe weight loss in the heart trial was less than the average of 15% weight loss in earlier Wegovy obesity studies before the drug was launched in the United States in June 2021. …

https://www.reuters.com/business/healthcare-pharmaceuticals/wegovy-weight-loss-sustained-four-years-trial-novo-nordisk-says-2024-05-13/

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