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Canada Regulatory Oversight Proposed Rules

Stikeman Elliott LLP

Canada Reconsiders Comparative Clinical Trials Requirements for Biosimilars

Stikeman Elliott LLP on

On June 10, 2025, Health Canada initiated a public consultation on proposed revisions to its Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs. A notable update is the proposal to remove...more

Stikeman Elliott LLP

FSRA Proposes New Regulatory Framework for Life and Health Managing General Agents in Ontario

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On January 28, 2025, the Financial Services Regulatory Authority of Ontario (“FSRA”) published Proposed Rule 2025-001 (the “Proposed Rule”), which builds on recent amendments to the Insurance Act (the “Act”). Those amendments...more

Bennett Jones LLP

Health Canada Consultation on Proposed Amendments to Address Drug and Medical Device Shortages in Canada

Bennett Jones LLP on

Health Canada is proposing to amend the Food and Drug Regulations, C.R.C., c.870 (the FDRs) and the Medical Device Regulations, SOR/98-282 (the MDRs) in an effort to avoid pharmaceutical and medical device shortages and...more

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