Health Canada Submission Under Review
Listing Websites about Health Canada Submission Under Review
Drug and Health Product Submissions Under Review …
(3 days ago) There are four Submissions Under Review (SUR) Lists, which contain: 1. new drug submissions currently under review 2. supplemental new drug submissions currently under review 3. new drug submissions formerly under review 4. supplemental new drug submissions formerly under review All four lists are updated … See more
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Drug and Health Product Submissions Under Review …
(4 days ago) WebSubmissions formerly under review: New drug submissions Medicinal Ingredient(s) Therapeutic Area Submission Control Number Year, Month Submission was Accepted into Review Year, Month Submission Concluded Outcome of Submission Footnote a; 5-Aminolevulinic acid: Antineoplastic agents: 234673: 2020-03: 2020-09: Issued Notice of …
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Health Canada disclosing more information on pending …
(6 days ago) WebOn February 23, 2024, Health Canada published a Notice advising that it was making its review process for generic drug submissions more transparent. Specifically, for generic drug submissions accepted into review on or after April 1, 2024, Health Canada will start disclosing: (i) the year and month that the submission was accepted for review; and (ii) …
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Drug and Health Product Submissions Under Review …
(2 days ago) WebPublisher - Current Organization Name: Health Canada Licence: Open Government Licence - Canada; Data and Resources new-drug submissions under-review; Subject: Health and Safety; Maintenance and Update Frequency: As Needed Date Published: 2023-06-22
https://open.canada.ca/data/en/info/80106243-6653-4c95-96a0-ee093ea71cbf
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Drug and Health Product Submissions Under Review …
(1 days ago) WebGovernment of Canada. All Contacts; Departments and agencies; About government; Themes and topics. Jobs; Immigration and citizenship; Travel and tourism; Business; Benefits; Health; Taxes; Environment and natural resources; National security and defence; Culture, history and sport; Policing, justice and emergencies; Transport and infrastructure
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Drug and Health Product Submissions Under Review (SUR)
(5 days ago) WebHow to access lists of drug submissions currently under review, and lists of certain drug submissions formerly under review. This initiative is funded by Health Canada's Substance Use and Addictions Program (SUAP). Production of this website has been made possible through a financial contribution from Health Canada. The views expressed
https://www.substanceusehealth.ca/resource/drug-and-health-product-submissions-under-review-sur
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New drug submission in Canada Health Canada data
(Just Now) WebHyperlinks from the Drug and Health Product Submissions Under Review website to the Drug and Health Product Register [4] were used to retrieve the reasons for Health Canada’s decisions along with the key information that the companies provided for their drugs and this information was entered onto the same spreadsheet. Health Canada
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Update on biosimilars in Canada - October 2021 - Smart & Biggar
(2 days ago) WebBiosimilar submissions under review. Health Canada provides a monthly update of new drug submissions under review (SUR). Since October 2018, the SUR has identified the sponsor, the filing date, and the submission class of the submission, including whether it is a biosimilar. The most recent SUR (as of October 25, 2021) …
https://www.smartbiggar.ca/insights/publication/update-on-biosimilars-in-canada-october-2021
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New drug submissions in Canada and a comparison with the Food …
(4 days ago) WebSince December 2015, Health Canada has been posting the outcomes of New Drug Submissions on its Drug and Health Product Submissions Under Review website . Outcomes include: canceled by sponsor; Notice of Compliance (market authorization); Notice of Compliance with conditions (market authorization with …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10270583/
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Canada: Coming Soon: Updated Generic Submissions Under …
(6 days ago) WebHealth Canada has published its long anticipated notice regarding changes to the Generic Submissions Under Review (GSUR) List. 1. The GSUR List currently identifies the medicinal ingredient (s), therapeutic area, and number of generic submissions under review with Health Canada. Health Canada has confirmed that it will soon also …
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Update on biosimilars in Canada – March 2023 - Smart & Biggar
(Just Now) WebBiosimilar submissions under review. Health Canada provides a monthly update of new drug submissions under review (SUR). Since October 2018, the SUR has identified the sponsor, the filing date, and the submission class of the submission, including whether it is a biosimilar. The most recent SUR (as of March 24, 2023) …
https://www.smartbiggar.ca/insights/publication/update-on-biosimilars-in-canada-march-2023
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Drug and Health Product Submissions Under Review (SUR)
(2 days ago) WebContact Email: [email protected] Keywords: Drug submission; submissions under review; drug and health product review and approval. Subject: Health and Safety; Maintenance and Update Frequency: As Needed Date Published: 2016-10-23
https://open.canada.ca/data/en/info/40b5d9f7-fafc-4a51-8fd9-7847a41401f8
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Health Canada Consulting On The Contents Of The Generic …
(3 days ago) WebOn January 7, 2019, Health Canada opened a consultation on whether to include the names of sponsor companies on the generic submissions under review list (GSUR) for Abbreviated New Drug Submissions (ANDSs).This type of information was recently added to the list of drug and health product submissions under review (SUR) …
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Health Canada's Proposal to Accelerate New Drug Reviews
(3 days ago) WebHealth Canada began a regulatory review of drugs and devices in 2017, and as part of this process, it issued a “Draft Guidance: Accelerated Review of Human Drug Submissions” to update its accelerated review pathways ( Health Canada 2019) and conducted a consultation on that document from May 7 to July 21, 2019 ( Government of Canada …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294445/
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Is Canada missing out? An assessment of drugs approved - CMAJ
(9 days ago) WebOf 230 new active substances with an approval by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA) or both between 2016 and 2020, 154 (67%) had been submitted for Health Canada approval by Feb. 10, 2023 ().Of those, 142 (92%) received a Notice of Compliance (NOC), 8 (5%) were under review …
https://www.cmaj.ca/content/195/23/E815
Category: Food, Medicine Show Health
List Of Generic Submissions Under Review Now Available - Mondaq
(2 days ago) WebFor submissions accepted into review on or after October 1, 2018, Health Canada now provides the following information: The new, separate Generic Submissions Under Review (GSUR) List includes a list of the generic submissions under review by medicinal ingredient. The preceding is intended as a timely update on Canadian …
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Drug and Health Product Submissions Under Review (SUR): …
(2 days ago) WebSubmissions formerly under review: Supplemental new drug submissions for new uses Publisher - Current Organization Name: Health Canada Licence: Open Government Licence - Canada
https://open.canada.ca/data/en/info/917dc978-8284-4c2c-8d50-39ab978b3e57
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Real-World Evidence to Reinforce Clinical Trial Evidence in Health
(7 days ago) WebBackground: Real-world evidence (RWE) can reinforce clinical trial evidence in health technology assessment (HTA). Objectives: Review HTA bodies’ (HTAbs) requirements for RWE, real uses, and acceptance across seven countries (Brazil, Canada, France, Germany, Italy, Spain, and the United Kingdom) and outline recommendations …
https://www.mdpi.com/2001-6689/12/2/9
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Drug and Health Product Submissions Under Review (SUR): New …
(2 days ago) WebContact Email: [email protected] Keywords: drug-and-health product submissions; submissions under review; SUR; new-drug submissions completed; Subject: Health and Safety; Maintenance and Update Frequency: As Needed Date Published: 2023-06-22
https://open.canada.ca/data/en/info/75f76896-b4c1-44af-bfed-edeee0eee3a1
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Hamilton child under 5 dies of measles: public health agency
(7 days ago) WebA Hamilton child under five years old has died of measles, says the city's public health agency. "This is a profoundly tragic situation where a young child has left us too soon with their whole
https://www.cbc.ca/news/canada/hamilton/measles-death-child-ontario-1.7207293
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