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
On May 5, 2025, the Ontario government introduced Bill 11, the proposed More Convenient Care Act, 2025 (“MCCA”), a legislative initiative aimed at supporting the province’s long-term healthcare goals for first reading. Bill...more
5/29/2025
/ Canada ,
Data Privacy ,
Digital Health ,
Health Care Providers ,
Healthcare ,
New Legislation ,
Patient Privacy Rights ,
Proposed Legislation ,
Regulatory Reform ,
Regulatory Requirements ,
Transparency
On February 27, 2025, the Government of Canada and Manitoba signed the first national pharmacare agreements under Canada’s Bill C-64, An Act respecting pharmacare (the “Pharmacare Act”), which received royal assent on October...more
3/11/2025
/ Canada ,
Drug Pricing ,
Government Agencies ,
Health Insurance ,
Health Technology ,
Healthcare ,
Healthcare Reform ,
New Legislation ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health
Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health...more
3/10/2025
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Clinical Trials ,
Distributors ,
Health Canada ,
Hemp ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Regulatory Agenda ,
Regulatory Requirements ,
THC
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
The Canadian government, through Environment and Climate Change Canada (“ECCC”), issued a notice (the “Notice”) under the Canadian Environmental Protection Act, 1999 (“CEPA”), outlining critical reporting requirements for...more
On November 21, 2024, the Office of the Superintendent of Financial Institutions (“OSFI”) released a regulatory notice on managing culture risk (the “Notice”). The Notice follows industry feedback on OSFI’s February 2023...more
On November 22, 2024, the Ontario Ministry of Finance announced that it is proceeding with a plan announced in Ontario’s 2024 Budget that will give the Financial Services Regulatory Authority (FSRA) the power to initiate a...more
On October 10, 2024, the Alberta Superintendent of Insurance issued Interpretation Bulletin 05-2024 (“Bulletin”) on the insurance regulatory treatment of motor vehicle warranty contracts, dealership loyalty programs and...more
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
The Regulations Amending Certain Regulations Concerning the Disclosure of Cosmetic Ingredients (SOR/2024-63) (the “Amended Cosmetic Regulations), published on April 24, 2024, took effect on October 9th (with the exception of...more
10/17/2024
/ Canada ,
Consumer Product Companies ,
Cosmetics ,
Manufacturers ,
New Regulations ,
Personal Care Products ,
Popular ,
Product Labels ,
Public Health ,
Regulatory Reform ,
Retail Market