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
6/25/2025
/ Biologics ,
Biosimilars ,
Canada ,
Clinical Trials ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Oversight ,
Regulatory Reform
Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received royal assent on October 10, 2024 and established a framework for national pharmacare. On February 27, 2025, the Hon. Mark Holland, Canada’s...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
1/20/2025
/ Canada ,
Health Canada ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Proposed Amendments ,
Proposed Rules ,
Public Health ,
Regulatory Agenda ,
Reporting Requirements ,
Supply Chain
On October 10, 2024, Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”) received Royal Assent. This legislation establishes a framework for a national universal pharmacare system, aiming to enhance the...more