Canada: Life Sciences, Biotechnology & Nanotechnology

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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.

Ontario Launches Health Innovation Pathway To Advance Health Technology And Patient Care

In an effort to improve patient outcomes and increase efficiency within Ontario's healthcare system, the provincial government has launched a new initiative: the Health Innovation Pathway (the "HIP").

Canada Healthcare

GL

Goodmans LLP

Growing Protection For Plant Varieties: Changes Coming To Canada's Plant Breeders' Rights Regulations

The Canadian Food Inspection Agency (CFIA) published proposed amendments to the Plant Breeders' Rights Regulations (PBR Regulations), initiating a public consultation period that will close on October 18, 2025.

Canada Healthcare

TL

Torys LLP

Medical Devices Updates: New Health Canada Guidance For Determining Medical Device Application Type And Medical Devices Directorate Performance Reports Released

As we previously reported, Health Canada completed consultation on its draft guidance for determining medical device application type.

Canada Healthcare

SB

Smart & Biggar

Health Canada And The Public Health Agency Of Canada Report On Red Tape Reduction Measures

In July 2025, the federal government issued a directive to federal regulators to examine their internal process and issue a report on where efficiencies can be achieved.

Canada Healthcare

GW

Gowling WLG

Can I Sue A Doctor Or Nurse?

Canada Healthcare

HS

Howie, Sacks & Henry LLP

A New Era: Health Canada Signals Modernization In Policy And Regulatory Reform

Canada Healthcare

BL

Borden Ladner Gervais LLP

Health Canada's Product Safety Pledge: A Model Product Safety Framework For Consumer Products And Cosmetics

Canada Healthcare

BL

Borden Ladner Gervais LLP

Canada's Plan Of Priorities Includes Several Nanoscale Materials

Canada Healthcare

BC

Bergeson & Campbell

Federal Court Of Appeal Confirms Generic Not Required To Address Patent Submitted Before ANDS Filing But Listed After

SB

Smart & Biggar

Important Changes To The Exception Patient Measure In Quebec

Canada Healthcare

F

Fasken

Episode 81: How Venture Capital Is Driving Innovation In Health Care (Podcast)

Canada Healthcare

D

Dentons Canada LLP

Patented Medicine Prices Review Board Publishes New Guidelines For PMPRB Staff: Finally, Some Guidance For Patentees

BL

Borden Ladner Gervais LLP

Les nouvelles lignes directrices du CEPMB sont enfin disponibles

Canada Healthcare

FF

Fasken (French)

The Court Grants An Appeal In Favour Of Psychedelic Assisted Psychotherapy – Toth v. Canada, 2025 FCA 119

Canada Healthcare

ML

McMillan LLP

Amendments To The Competition Act Only One Step Towards A Truly Competitive Economy

Canada Anti-trust

F

Fasken

The New Reality: Navigating Rising IRCC Refusal Rates In 2025

Canada Immigration

S

Sobirovs Law Firm

Regulating Deepfakes Through Copyright: Would Denmark's Proposed Approach Be Right For Canada?

MT

Miller Thomson LLP

Comment traiter les tarifs douaniers et autres obstacles à l'accès aux marchés au moyen du mécanisme de règlement des différends entre investisseurs et États

Canada International

MT

McCarthy Tétrault LLP

U.S. Releases New Process For Expanding Auto Parts Tariffs: What Canadian Stakeholders Need To Know

Canada International

BL

Borden Ladner Gervais LLP

2025 Mid-year Highlights In Canadian Life Sciences IP And Regulatory Law

In the first half of 2025, the Rx IP Update team reported on a number of developments in Canadian life sciences IP and regulatory law. Below are our top stories.

Canada Healthcare

SB

Smart & Biggar

Important New Procedural Guidelines From The PMPRB

The Patented Medicine Prices Review Board (PMPRB) is a Canadian federal agency that regulates the prices of patented medicines in Canada.

AM

Aird & McBurney LP

Final Guidelines From Canada's PMPRB: The New Era Begins

On June 30, 2025, the PMPRB published final non-binding guidelines (Guidelines) titled Guidelines for PMPRB Staff: Administrative Process for Excessive Price Hearing Recommendation.

TL

Torys LLP

Finalized PMPRB Guidelines Published

On June 30, 2025, the Patented Medicine Prices Review Board (PMPRB) published its new Guidelines for PMPRB Staff, which will come into force on January 1, 2026.

SB

Smart & Biggar

At Long Last: The New PMPRB Guidelines Are Here

Worldwide Healthcare

F

Fasken

CDA Opens Consultation On Proposed List Of Drugs To Inform Development Of National Formulary

Canada Healthcare

SB

Smart & Biggar

Closing The Value Gap Using Earnouts In Life Sciences M&A

Canada Healthcare

AB

Aird & Berlis LLP

Health Canada Must Redetermine Exemption Requests For Psilocybin (Magic Mushroom)-Assisted Psychotherapy Training

Canada Healthcare

SB

Smart & Biggar

Update On Biosimilars In Canada – June 2025

Canada Healthcare

SB

Smart & Biggar

Updated PMPRB Guidelines Expected In Summer 2025 And NPDUIS Releases Ninth Edition Of The Meds Entry Watch Report

Canada Healthcare

SB

Smart & Biggar

La nouvelle ébauche de la Ligne directrice de Santé Canada sur les médicaments biologiques biosimilaires

Canada Healthcare

FF

Fasken (French)

Health Canada Consultation On Revised Biosimilar Guidance: No Requirement For Comparative Clinical Efficacy And Safety Trials

Canada Healthcare

SB

Smart & Biggar

Biosimilar Update: Health Canada Reconsiders Requirement For Comparative Clinical Trials

Canada Healthcare

MT

McCarthy Tétrault LLP

Apotex Not Entitled To Damages For Delayed Generic Drug Launch

TS

Tierney Stauffer LLP

La nouvelle ébauche de la Ligne directrice de Santé Canada sur les médicaments biologiques biosimilaires

Le 10 juin 2025, Santé Canada a publié une ébauche des nouvelles « Lignes directrices : Exigences en matière de renseignements et de présentation relatives aux médicaments biologiques biosimilaires...

Canada Healthcare

FF

Fasken (French)

Health Canada Consultation On Revised Biosimilar Guidance: No Requirement For Comparative Clinical Efficacy And Safety Trials

On June 10, 2025, Health Canada launched a consultation on its Draft Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs...

Canada Healthcare

SB

Smart & Biggar

Biosimilar Update: Health Canada Reconsiders Requirement For Comparative Clinical Trials

Health Canada has released a draft version of an amended Guidance Document on biosimilar submission requirements (link here). In a significant reversal of policy...

Canada Healthcare

MT

McCarthy Tétrault LLP

Apotex Not Entitled To Damages For Delayed Generic Drug Launch

The Ontario Court of Appeal's recent decision in Apotex Inc. v. Eli Lilly and Company offers important clarity for pharmaceutical companies engaged in patent litigation under the Patented Medicines (Notice of Compliance) Regulations ("NOC Regulations").

TS

Tierney Stauffer LLP

CDA Update: New Five-Year Strategic Plan And Position Statement On Using AI In Health Technology Assessments

Canada Healthcare

SB

Smart & Biggar

Santé Canada exempte temporairement les produits de santé naturels nouvellement homologués des nouvelles exigences d'étiquetage

Les PSN homologués à partir de cette date devaient se conformer aux nouvelles exigences dès le départ, tandis que ceux homologués avant cette date bénéficiaient d'une période de transition...

Canada Healthcare

FF

Fasken (French)

5 Key Trends Shaping The Life Sciences Industry (Video)

What trends are driving change this year in the life sciences industry?

Canada Healthcare

RS

RSM Canada

Licensing Partnerships In Life Sciences: Emerging And Expected Trends In 2025

With the year well underway, it's an opportune time to examine the emerging and expected trends in 2025 for licensing partnerships in the life sciences industry.

Canada Healthcare

GW

Gowling WLG

Instruments médicaux basés sur l'IA — Transformation et réglementation

L'utilisation de l'intelligence artificielle (l'« IA ») dans le cadre de la prestation de soins de santé crée des opportunités transformationnelles pour l'amélioration des systèmes et des soins...

Canada Healthcare

MT

McCarthy Tétrault LLP

Some Things Last Forever: Government Of Canada Proposes Regulatory Measures For PFAS

Canada Environment

OH

Osler, Hoskin & Harcourt LLP

Health Canada Seeks Input On New Draft Guidance For Co-packaged Drug Products

Canada Healthcare

SB

Smart & Biggar

Canada's Drug Agency Releases 2025 Watch List Highlighting AI Technologies In Health Care

Canada Healthcare

SB

Smart & Biggar

Trade War Update: Relief For Some As Canada Orders Six-Month Reprieve On Retaliatory Tariffs On A Wide Range Of Imported Goods

Canada International

MT

McCarthy Tétrault LLP

Who Owns A Thought? Navigating Legal Issues In Neurotech

Canada Healthcare

ML

McMillan LLP

AI-Enabled Medical Devices: Transformation And Regulation

Canada Healthcare

MT

McCarthy Tétrault LLP

L'influence de l'IA sur le domaine de la santé au Canada

Canada Technology

MT

Miller Thomson LLP

Government Of Canada Announces First Pharmacare Agreements

Canada Healthcare

SB

Smart & Biggar

Pre-Market Considerations For Machine Learning-Enabled Medical Devices

Canada Healthcare

F

Fasken

Private Competition Tribunal Challenges To Abuse Of Dominance: A JAMPing Off Point

Canada Anti-trust

ML

McMillan LLP

PMPRB Announces Anie Perrault As Acting Chairperson And Releases Latest Expenditure Report On Private Drug Plan Costs And Utilization

Canada Healthcare

SB

Smart & Biggar

Health Canada Publishes Guidance On Submitting Risk Management Plans

Canada Healthcare

SB

Smart & Biggar

Canada Concludes PFAS "Forever Chemicals" Are Toxic: What You Need To Know

Canada Environment

BL

Borden Ladner Gervais LLP

SCC To Revisit "Method Of Medical Treatment" Patent Claims

SB

Smart & Biggar

Canada Moves To Add PFAS To List Of Toxic Substances; Proposes Risk Management Strategy

Canada Environment

TL

Torys LLP

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Latest Videos

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Lois canadiennes, américaines, britanniques et européennes entourant l'Internet des objets (Video)

BL

Borden Ladner Gervais LLP

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

PM

Parlee McLaws

Navigating (and Challenging) A Changing Life Sciences Regulatory Environment (Video)

TL

Torys LLP

Le Secteur De La Santé Au Canada Après La COVID-19 : Perspectives Juridiques, Médicales Et Commerciales (vidéos)

SE

Stikeman Elliott LLP

Lifecycle Of A Smart Idea: Patent Strategy - Optimising Life Sciences Patents (Video)

GW

Gowling WLG

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