Canada: Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.

Health Canada Issues Revised Biosimilar Guidance Reducing Clinical Evidence Requirements For Biosimilar Approval

Health Canada has issued a new Guidance Document pertaining to biosimilar drug submissions. The new Guidance significantly reduces the supporting clinical safety...

Canada Healthcare

GW

Gowling WLG

Health Canada Publishes Medical Devices Directorate Quarterly Performance Reports For Q2 And Q3 Of 2025/2026

In January and February 2026, Health Canada released the Quarterly Report for Q2 2025-2026 (July through September 2025) and for Q3 2025-2026 (October through December 2025).

Canada Healthcare

SB

Smart & Biggar

Medical Devices Updates: Mandatory Use Of The Regulatory Enrolment Process For Medical Devices And Updated Guidance Documents Related To The Regulatory Enrolment Process

Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024.

Canada Healthcare

SB

Smart & Biggar

PMPRB Releases May NEWSLetter And Meds Pipeline Monitor

On May 12, 2026, the Patented Medicine Prices Review Board (PMPRB) released its May NEWSLetter. The NEWSletter provides updates on the implementation of the new Guidelines for PMPRB Staff, the consultation of the proposed Hearing Practice Directions, events in which the PMPRB participated, and new and upcoming NPDUIS research publications.

Canada Healthcare

SB

Smart & Biggar

Canada’s Drug Agency Releases Updated Procedures For Reimbursement Reviews & New Data On Health Technology Assessment Timelines

Canada Healthcare

SB

Smart & Biggar

Health Canada Seeks Feedback On Phased Implementation Of The Incorporated By Reference List For Ministerial Reliance Order

Canada Healthcare

SB

Smart & Biggar

Life Sciences Outlook 2026

Canada Healthcare

BJ

Bennett Jones LLP

Episode 100: Navigating Growth And Leadership In Mental Healthcare (Podcast)

Canada Healthcare

D

Dentons Canada LLP

Health Canada Proposes To Exempt Certain Low-risk Non-prescription Drugs From “New Drug” Requirements

Canada Healthcare

GW

Gowling WLG

Health Professions And Occupations Act: An Overhaul To Regulation Of British Columbia Health Care Practitioners

Canada Healthcare

SU

Singleton Urquhart Reynolds Vogel LLP

BCF Acts As Counsel To Celystra Pharma As Part Of An Equity Investment

Canada Healthcare

BB

BCF Business Law

Les aspects réglementaires et liés à la propriété intellectuelle encadrant les médicaments vétérinaires au Canada

Canada Healthcare

SB

Smart & Biggar

Le problème des DIN dormants au Canada : comment le statut de commercialisation sape les protections de la PI pharmaceutique prévues à l’ACEUM

Canada Healthcare

MT

McCarthy Tétrault LLP

Episode 99: Embracing Life's Possibilities With Intentionality And Connection (Podcast)

Canada Healthcare

D

Dentons Canada LLP

A Practical Guide For Business Owners Expanding Or Relocating To Ontario, Canada (Video)

Canada Commercial

LL

Lerners LLP

Les Excuses En Cas De Diffamation : Une Solution Plus Symbolique Que Juridique?

Canada Litigation

BB

BCF Business Law

QSBC Shares And The 24 Month Holding Period Requirement

L

Linmac

Closing The Loophole On Indirect Trust Transfers And The 21-Year Deemed Disposition Rule: New Measure In Budget 2025

RS

Rotfleisch & Samulovitch P.C.

How To Master The 24-Month Holding Period Requirement For QSBC Shares And Lifetime Capital Gains Exemption In Canada

RS

Rotfleisch & Samulovitch P.C.

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Food and Drugs Law

Health Canada Issues Revised Biosimilar Guidance Reducing Clinical Evidence Requirements For Biosimilar Approval

Health Canada has issued a new Guidance Document pertaining to biosimilar drug submissions. The new Guidance significantly reduces the supporting clinical safety...

Canada Healthcare

GW

Gowling WLG

PMPRB Releases May NEWSLetter And Meds Pipeline Monitor

On May 12, 2026, the Patented Medicine Prices Review Board (PMPRB) released its May NEWSLetter. The NEWSletter provides updates on the implementation of the new Guidelines for PMPRB Staff, the consultation of the proposed Hearing Practice Directions, events in which the PMPRB participated, and new and upcoming NPDUIS research publications.

Canada Healthcare

SB

Smart & Biggar

Canada’s Drug Agency Releases Updated Procedures For Reimbursement Reviews & New Data On Health Technology Assessment Timelines

On April 30, 2026, Canada’s Drug Agency (CDA) published updated Procedures for Reimbursement Reviews, following completion of a public consultation earlier this year. The updated procedures will be effective for August 2026 submissions and expert committee meetings in January 2027.

Canada Healthcare

SB

Smart & Biggar

Health Canada Seeks Feedback On Phased Implementation Of The Incorporated By Reference List For Ministerial Reliance Order

Canada Healthcare

SB

Smart & Biggar

Dormant DINs Revisited: MFN Pricing And The Evolving Impacts On Canada’s Patent Linkage Regime

F

Fasken

Health Canada Proposes To Exempt Certain Low-risk Non-prescription Drugs From “New Drug” Requirements

Canada Healthcare

GW

Gowling WLG

Les aspects réglementaires et liés à la propriété intellectuelle encadrant les médicaments vétérinaires au Canada

Canada Healthcare

SB

Smart & Biggar

Crime Does Not Pay, Even Without A Conviction: New Legal Test For Criminal Forfeiture Under Section 490(9) Of The Criminal Code Set Out In R V. Nguyen, 2026 SCC 10

Canada Criminal

AH

Alexander Holburn Beaudin + Lang LLP

Le problème des DIN dormants au Canada : comment le statut de commercialisation sape les protections de la PI pharmaceutique prévues à l’ACEUM

Canada Healthcare

MT

McCarthy Tétrault LLP

See more

Life Sciences, Biotechnology & Nanotechnology

Medical Devices Updates: Mandatory Use Of The Regulatory Enrolment Process For Medical Devices And Updated Guidance Documents Related To The Regulatory Enrolment Process

Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024.

Canada Healthcare

SB

Smart & Biggar

Health Canada Publishes Medical Devices Directorate Quarterly Performance Reports For Q2 And Q3 Of 2025/2026

In January and February 2026, Health Canada released the Quarterly Report for Q2 2025-2026 (July through September 2025) and for Q3 2025-2026 (October through December 2025).

Canada Healthcare

SB

Smart & Biggar

Life Sciences Outlook 2026

As part of a deeply interconnected global sector, the life sciences industry in Canada is undergoing significant change alongside broad macroeconomic and geopolitical shifts.

Canada Healthcare

BJ

Bennett Jones LLP

BCF Acts As Counsel To Celystra Pharma As Part Of An Equity Investment

Canada Healthcare

BB

BCF Business Law

Ontario Superior Court Limits Damages Claims In Certifying Personal Injury Medical Device Class Action

Canada Litigation

BJ

Bennett Jones LLP

Northern Advantage: Canada's Federal Court As A Venue For Pharmaceutical Patent Litigation

BJ

Bennett Jones LLP

Deference Prevails: A Public Drug Funding Decision In Québec Is Upheld On Reasonableness Review

Canada Healthcare

TL

Torys LLP

Class Action Pursued Over Infection Risks Linked To Endoscope Devices

Canada Consumer

SL

Siskinds LLP

Tout ce qu'il faut savoir sur les lignes directrices mises à jour et les exemples 2026 de l'OPIC concernant l'objet brevetable

SB

Smart & Biggar

See more

Healthcare

Health Canada Issues Revised Biosimilar Guidance Reducing Clinical Evidence Requirements For Biosimilar Approval

Health Canada has issued a new Guidance Document pertaining to biosimilar drug submissions. The new Guidance significantly reduces the supporting clinical safety...

Canada Healthcare

GW

Gowling WLG

Health Canada Publishes Medical Devices Directorate Quarterly Performance Reports For Q2 And Q3 Of 2025/2026

In January and February 2026, Health Canada released the Quarterly Report for Q2 2025-2026 (July through September 2025) and for Q3 2025-2026 (October through December 2025).

Canada Healthcare

SB

Smart & Biggar

Medical Devices Updates: Mandatory Use Of The Regulatory Enrolment Process For Medical Devices And Updated Guidance Documents Related To The Regulatory Enrolment Process

Health Canada released a notice to industry on April 24, 2026, outlining that manufacturers must use the Regulatory Enrolment Process (REP) and Common Electronic Submission Gateway (CESG) for medical device transactions as of April 1, 2026. As we previously reported, manufacturers of medical devices could voluntarily use the REP and CESG for medical device regulatory transactions as of July 2024.

Canada Healthcare

SB

Smart & Biggar

PMPRB Releases May NEWSLetter And Meds Pipeline Monitor

Canada Healthcare

SB

Smart & Biggar

Canada’s Drug Agency Releases Updated Procedures For Reimbursement Reviews & New Data On Health Technology Assessment Timelines

Canada Healthcare

SB

Smart & Biggar

Health Canada Seeks Feedback On Phased Implementation Of The Incorporated By Reference List For Ministerial Reliance Order

Canada Healthcare

SB

Smart & Biggar

Future Care Costs Case Studies: What Is Reasonable?

Canada Litigation

MB

McCague Borlack LLP

Dormant DINs Revisited: MFN Pricing And The Evolving Impacts On Canada’s Patent Linkage Regime

F

Fasken

Episode 100: Navigating Growth And Leadership In Mental Healthcare (Podcast)

Canada Healthcare

D

Dentons Canada LLP

See more

Latest Videos

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Bothwell V. London Health Sciences Centre, 2023 ONCA 323; Mental Health Injury Update (Video)

SB

SBA Lawyers LLP

Building A Credible Case On Damages With Monika Brunner And Roger Shoreman (Video)

GP

Gluckstein Lawyers

What's Next For Ontario's Public Health Care? (Video)

F

Fasken

The Legal Steps To Startups: Health & Life Science (Video)

PM

Parlee McLaws

From Discovery To Market: The Role Of IP Strategy In Drug Development (Video)

GW

Gowling WLG

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