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.

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

On June 30, the Patented Medicine Prices Review Board (PMPRB) published new Guidelines for PMPRB Staff (the Guidelines) that will take effect on Jan. 1, 2026.

BL

Borden Ladner Gervais LLP

Les nouvelles lignes directrices du CEPMB sont enfin disponibles

Le 30 juin, le Conseil d'examen du prix des médicaments brevetés (le « CEPMB ») a publié les Lignes directrices pour le personnel du CEPMB...

Canada Healthcare

FF

Fasken (French)

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

A ruling from the Federal Court of Canada has resulted in an appeal of prior government refusals to permit access to psilocybin in connection with psilocybin assisted psychotherapy ("PSAP").

Canada Healthcare

ML

McMillan 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

AM

Aird & McBurney LP

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

TL

Torys LLP

Finalized PMPRB Guidelines Published

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)

Frustration Of Contract: When Performance Becomes Impossible

Canada Employment

MB

McCague Borlack LLP

How CRA Conducts Net Worth Audits And Enforces Gross Negligence Penalties Against Canadian Taxpayers: Lessons From Mann v. The King And Other Cases

RS

Rotfleisch & Samulovitch P.C.

CRA Unveils New Process For Canadian Taxpayers To Authorize Their Tax Representatives To Access Their Online CRA Account Using "Authorize A Representative"

RS

Rotfleisch & Samulovitch P.C.

Webinar: 2025 Global In-House Counsel Survey Report: Unique Insights Into The Global In-House Counsel Profession

Worldwide Law Practice

IC

In-House Counsel Worldwide

Tokenized Carbon Credits: How Blockchain Is Revolutionizing Carbon Markets

Canada Technology

OH

Osler, Hoskin & Harcourt LLP

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

On April 15, 2025, Canada's Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA's first strategic plan.

Canada Healthcare

SB

Smart & Biggar

Les incidences du projet de loi 83 sur les médecins et le système de santé du Québec

Canada Healthcare

FF

Fasken (French)

2024 Deal Points Report: Venture Capital Financings

Canada Commercial

OH

Osler, Hoskin & Harcourt LLP

Court Finds Eculizumab Patent Neither Anticipated Nor Obvious

AK

Aitken Klee

Health Canada Temporarily Exempts Newly Licensed Natural Health Products From New Labelling Requirements

Canada Healthcare

F

Fasken

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

Canada Healthcare

FF

Fasken (French)

5 Key Trends Shaping The Life Sciences Industry (Video)

Canada Healthcare

RS

RSM Canada

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

Canada Healthcare

GW

Gowling WLG

Instruments médicaux basés sur l'IA — Transformation et réglementation

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

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

On March 5, 2025, the Government of Canada proposed new regulatory measures for per- and polyfluoroalkyl substances (PFAS), which it outlines in the final State of Per- and Polyfluoroalkyl...

Canada Environment

OH

Osler, Hoskin & Harcourt LLP

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

On March 18, 2025, Health Canada released a Notice that it is seeking feedback on a draft guidance on 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

Government Of Canada Announces First Pharmacare Agreements

In connection with Royal Assent of the Pharmacare Act, we previously reported that the Minister of Health intended to negotiate bilateral agreements with provinces and territories to provide universal.

Canada Healthcare

SB

Smart & Biggar

Pre-Market Considerations For Machine Learning-Enabled Medical Devices

Artificial intelligence (AI) encompasses algorithms designed for tasks such as learning, decision-making, and prediction. Machine learning (ML), a subset of AI...

Canada Healthcare

F

Fasken

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

The Canadian Competition Act has seen a whirlwind of changes over the past three years, as outlined in a number of recent McMillan bulletins.

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

On March 6, 2025, the Patented Medicine Prices Review Board (PMPRB) announced that Thomas Digby stepped down from his role as Chairperson of the PMPRB.

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

Le Manitoba devient la première province à adhérer au régime national d'assurance-médicaments

Canada Healthcare

MT

McCarthy Tétrault LLP

The Evolving Tariff Threat: Impact On Hospitals In Canada

Canada International

BL

Borden Ladner Gervais LLP

Changes To Canada's Food And Drug Regulations And Medical Devices Regulations

Canada Healthcare

TL

Torys LLP

The Evolving Tariff Threat: Impact On Med-Tech And Life Science Industries

Canada Healthcare

BL

Borden Ladner Gervais LLP

Règlement projeté visant à réduire les pénuries de médicaments et d'instruments médicaux au Canada

Canada Healthcare

FF

Fasken (French)

Minister Of Health Announces New Bilateral Agreements With Provinces For Rare Disease Drugs

Canada Healthcare

SB

Smart & Biggar

Diversification Opportunities For Canada's Life Sciences Businesses In South Korea

Worldwide Healthcare

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Fasken

Proposed Regulations To Mitigate Drug And Device Shortages In Canada

Canada Healthcare

F

Fasken

Health Canada Proposes Regulations To Mitigate Drug And Medical Device Shortages

Canada Healthcare

BC

Blake, Cassels & Graydon LLP

Health Canada's Evolving Regulatory Framework For Machine Learning-enabled Medical Devices

Canada Healthcare

BL

Borden Ladner Gervais LLP

Compliance And Safety Considerations For Running An Online Pharmacy

Canada Healthcare

MA

MLT Aikins 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

IP For Life Sciences Startups: Protecting Your Most Valuable Assets (Video)

GW

Gowling WLG

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

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