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.

Health Canada Proposes Amendments To MDEL Holders And Applicants

On November 8, 2025, the Department of Health published proposed amendments to the Medical Devices Regulations, SOR/98-282 (MDR) with a specific...

Worldwide Healthcare

BJ

Bennett Jones LLP

Consultation sur les modifications proposées aux exigences relatives aux licences d'établissement d'instruments médicaux

Le 8 novembre 2025, Santé Canada a publié le Règlement modifiant le Règlement sur les instruments médicaux (licences d'établissement) (le « projet de règlement ») dans La Gazette du Canada...

Canada Healthcare

BC

Blake, Cassels & Graydon LLP

Practical Tips On Patent Term Adjustment In Canada

Patent term adjustment (PTA) to compensate for unreasonable delays at the Canadian Intellectual Property Office (CIPO) may apply to Canadian patents granted...

BL

Borden Ladner Gervais LLP

L'APP lance une voie révisée pour les négociations non complexes concernant le prix de médicaments

L'Alliance pharmaceutique pancanadienne (« APP ») a récemment annoncé qu'elle officialisait et lançait son processus de négociation ciblé (« PNC ») révisé.

Canada Healthcare

SB

Smart & Biggar

December 2025 Rosen Sunshine Newsletter

Canada Healthcare

RS

Rosen Sunshine LLP

L'Ontario propose des mesures législatives pour encadrer les réseaux de fournisseurs privilégiés

Canada Healthcare

SB

Smart & Biggar

Branding Medical Devices: Balancing Brand Protection And Regulation

Canada Healthcare

ML

McMillan LLP

Ontario proposes legislation to regulate preferred provider networks

Canada Healthcare

SB

Smart & Biggar

PCPA Introducing Revisions To Pathway For Non-complex Drug Negotiations

Canada Healthcare

SB

Smart & Biggar

La Cour d'appel fédérale confirme qu'il n'est pas nécessaire de tenir compte des demandes de brevets déposées avant la présentation abrégée de drogue nouvelle pour un médicament générique, mais inscrites au registre après

SB

Smart & Biggar

Les tendances observées dans les demandes de brevets relatives aux technologies médicales assistées par l'intelligence artificielle

SB

Smart & Biggar

Un programme pilote de l'Ontario ainsi qu'une nouvelle voie de négociation de l'APP pour accélérer l'accès à des traitements novateurs contre le cancer

Canada Healthcare

SB

Smart & Biggar

Le CEPMB publie son Rapport annuel sur les dépenses des régimes publics d'assurance médicaments (2022-2023)

Canada Healthcare

SB

Smart & Biggar

Santé Canada publie son Rapport statistique 2024/2025 pour le Règlement sur les médicaments brevetés (avis de conformité), la protection des données et les certificats de protection supplémentaire

SB

Smart & Biggar

Financial Services Regulatory Authority Of Ontario's New Proposed Life And Health Managing General Agents Rule

TL

Torys LLP

Share Redemption And Share Retraction: Tax Treatment By CRA—plus They Are Useful Tax Planning Tools

RS

Rotfleisch & Samulovitch P.C.

Navigating The Relationship Between Retail Funds And Institutional Capital

TL

Torys LLP

Une signature électronique est-elle suffisante? Comprendre la perfection par possession à l'ère numérique au Canada

MT

Miller Thomson LLP

Federal Budget 2025: Implications For The Financial Sector

BL

Borden Ladner Gervais LLP

L'AMC publie sa stratégie visant l'amélioration de la prescription et de l'utilisation appropriées des médicaments d'ordonnance au Canada

Le 18 septembre 2025, L'Agence des médicaments du Canada a lancé sa nouvelle stratégie visant l'amélioration de la prescription et de l'utilisation appropriées...

Canada Healthcare

SB

Smart & Biggar

La Cour suprême du Canada a mis en délibéré son jugement dans le cadre de l'appel relatif à la brevetabilité des méthodes de traitement médical

Il y a plus de 10 ans, la Cour d'appel fédérale (CAF) avait signalé que la brevetabilité des méthodes de traitement médical méritait que la Cour suprême...

SB

Smart & Biggar

Ontario Moves To Regulate Preferred Pharmacy Networks (PPNs)

The government of Ontario has signaled its intention to formally regulate preferred pharmacy networks ("PPNs") in employer-sponsored drug benefit plans.

Canada Healthcare

F

Fasken

Santé Canada cherche à réduire le fardeau administratif en renforçant la collaboration, l'alignement et la confiance à l'échelle internationale

En juillet 2025, le gouvernement du Canada a entrepris un « examen du fardeau administratif » dans l'ensemble des ministères fédéraux afin de moderniser les cadres réglementaires et de soutenir la croissance économique.

Canada Healthcare

SB

Smart & Biggar

Huitième anniversaire des modifications majeures apportées au Règlement sur les MB (AC)

SB

Smart & Biggar

Faits saillants du premier semestre 2025 au Canada en matière de la PI en sciences de la vie et de droit règlementaire

SB

Smart & Biggar

Publication de la version définitive des Lignes directrices du CEPMB

Canada Healthcare

SB

Smart & Biggar

L'AMC ouvre une consultation sur la liste provisoire de médicaments pour guider l'élaboration d'une liste nationale de médicaments assurés

Canada Healthcare

SB

Smart & Biggar

Mise à jour sur les instruments médicaux : nouvelles lignes directrices de Santé Canada pour déterminer les types de demandes relatives aux instruments médicaux et publication des rapports sur le rendement de la Direction des instruments médicaux

Canada Healthcare

SB

Smart & Biggar

Rosen Sunshine Newsletter - November 2025

Canada Healthcare

RS

Rosen Sunshine LLP

Streamlined Biosimilar Approvals: What The End Of Biosimilar Phase III Trials Means For Innovative Pharmaceutical Patent Holders

Canada Healthcare

MT

McCarthy Tétrault LLP

Recent Biologics Decisions At Health Canada

Canada Healthcare

GP

Goodwin Procter LLP

Ontario Pilot Program And PCPA New Negotiation Pathway Aim To Expedite Access To Breakthrough Cancer Treatments

Canada Healthcare

SB

Smart & Biggar

Santé Canada et l'Agence de la santé publique du Canada publient un rapport sur la réduction du fardeau administratif

Canada Healthcare

BC

Blake, Cassels & Graydon LLP

Streamlined Biosimilar Approvals: What The End Of Biosimilar Phase III Trials Means For Innovative Pharmaceutical Patent Holders

The U.S. Food and Drug Administration (FDA) has released a landmark draft guidance on biosimilar submission requirements (the "draft guidance", link here).

Canada Healthcare

MT

McCarthy Tétrault LLP

Recent Biologics Decisions At Health Canada

In the last few weeks, Health Canada issued several decisions concerning biologics.

Canada Healthcare

GP

Goodwin Procter LLP

Ontario Pilot Program And PCPA New Negotiation Pathway Aim To Expedite Access To Breakthrough Cancer Treatments

The Ontario government and the pan-Canadian Pharmaceutical Alliance (pCPA) announced separate initiatives in October 2025, both aimed to accelerate patient access to breakthrough cancer treatments approved through the Project Orbis pathway.

Canada Healthcare

SB

Smart & Biggar

Santé Canada et l'Agence de la santé publique du Canada publient un rapport sur la réduction du fardeau administratif

En réponse aux préoccupations des parties prenantes au sujet des processus administratifs obsolètes et trop prescriptifs, le gouvernement du Canada a lancé un examen du fardeau...

Canada Healthcare

BC

Blake, Cassels & Graydon LLP

CDA Releases Strategy To Improve The Appropriate Prescribing And Use Of Prescription Medications In Canada

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?

Doctors and nurses in Canada can be sued for medical malpractice (also called medical negligence) if they provide care that falls below the accepted medical standard and that failure causes...

Canada Healthcare

HS

Howie, Sacks & Henry LLP

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

On Sept. 8, 2025, Health Canada and the Public Health Agency of Canada published their Report on Red Tape Reduction, outlining their key regulatory modernization initiatives aimed at improving efficiency, transparency and responsiveness within Canada's health system.

Canada Healthcare

BL

Borden Ladner Gervais LLP

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

On August 25, 2025, Health Canada released its first annual report (the Report) summarizing anonymized self assessment data received in respect of the reporting period beginning September 29, 2023, and ending September 28, 2024, from signatories to the Canadian Product Safety Pledge 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

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

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

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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

Financing Life Sciences On Both Sides Of The Border (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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