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Health Canada releases new guidance document on clinical …

WEBOn November 15, 2022, Health Canada released a new guidance document, “ Guidance on clinical evidence requirements for medical devices.” In it, …

Actived: 6 days ago

URL: https://www.smartbiggar.ca/insights/publication/health-canada-releases-new-guidance-document-on-clinical-evidence-requirements-for-medical-devices

Updates to Health Canada’s regulatory initiatives for 2022-2024, …

WEBHealth Canada has updated its Forward Regulatory Plan: 2022-2024, providing information on regulatory initiatives Health Canada aims to propose or finalize …

Category:  Health Go Health

Health Canada paving the way for more AI/ML medical devices

WEBThe document consists of 10 guiding principles to help promote safe, effective, and high-quality use of artificial intelligence and machine learning (AI/ML) in …

Category:  Health Go Health

Biosimilars: Comparison chart between Canada, US and Europe

WEBWe have collaborated with Brian Coggio of Fish & Richardson, and Mary Foord-Weston and Camilla Balleny of Carpmaels & Ransford to prepare the chart below …

Category:  Health Go Health

Update on biosimilars in Canada – March 2024

WEBOn March 29, 2023, the Government of Yukon announced the Yukon Biosimilar Initiative. The first phase switched patients taking adalimumab and insulin …

Category:  Health Go Health

Health Canada issues interim policy re: interpretation of “medicinal

WEBThe Interim Policy states: Following the court's decision and for regulatory consistency, Health Canada has reassessed its interpretation of "medicinal ingredient" …

Category:  Health Go Health

Update on biosimilars in Canada – June 2022

WEBAuthored by Urszula Wojtyra. June 28, 2022. Update: Biosimilars in Canada – March 2023 is available to view online. We provide a further update on developments …

Category:  Health Go Health

Final regulations addressing the public release of clinical …

WEBOn March 4, 2019, the final Regulations Amending the Food and Drug Regulations (Public Release of Clinical Information) and Regulations Amending the Medical Devices …

Category:  Food,  Medical Go Health

Biosimilars approved in Canada

WEBBiosimilars are subsequent entry versions of a Canadian-approved innovator biologic. The table below provides an overview of biosimilars approved by Health Canada. Canada’s …

Category:  Health Go Health

Update on biosimilars in Canada

WEBSince our last update in April 2021, there have been many developments regarding biosimilars in Canada (approvals, pending submissions, litigation, regulatory …

Category:  Health Go Health

First year of Project Orbis leads to 38 approvals of cancer therapies

WEBAccording to a recent publication by the Project Orbis partnership, the program received 60 oncology marketing applications in the first year, resulting in 38 …

Category:  Health Go Health

Canadian Patent Law 2021: A round-up of interesting …

WEBThe Federal Court of Appeal affirmed a Federal Court decision ( 2021 FC 345) dismissing Merck’s application for judicial review of the Minister of Health’s refusal …

Category:  Health Go Health

Health Canada updates Guidance Document: The Management of …

WEBAuthored by Katie Lee. September 30, 2019. On July 25, 2019, Health Canada released an updated version of the Guidance Document: The Management of …

Category:  Health Go Health

COVID-19 Update: CIPO, Federal Courts, Health Canada

WEBThe Federal Court dismissed Merck’s judicial review application of the Minister’s decision that the 30-day time limit under s. 4 (6) for submitting a patent list …

Category:  Health Go Health

Health Canada amends Drug Sampling Laws and issues Guidance …

WEBAs mentioned, under the amendments (1) certain low-risk NHPs will be treated like certain low-risk OTC DIN drugs with respect to direct sampling to …

Category:  Health Go Health

On the (Quebec Health) Record: the Federal Court holds the …

WEBToday’s fast-paced innovation economy demands a higher level of expertise and attention to detail when it comes to IP. Our highly skilled team of lawyers, patent …

Category:  Health Go Health

2022 Highlights in Canadian Life Sciences IP and Regulatory Law

WEB2. PMNOC Regulations: Fifth-year anniversary of major amendments, marketing requirement . In September, we provided a fifth anniversary update on cases …

Category:  Health Go Health

Natural and Non-Prescription Health Products Directorate

WEBNatural and Non-Prescription Health Products Directorate Drug Submission Performance Annual Report Fiscal Year 2021-2022 April 1 2021 - March 31 2022

Category:  Health Go Health

Guidance Document Re: Reporting Adverse Reactions to Marketed …

WEBT: 647.798.0020. [email protected]. On May 23, 2018, Health Canada published Overview of the Reporting Adverse Reactions to Marketed Health …

Category:  Health Go Health

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