European Union: 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.

Development Of A New EMA Guideline On The Clinical Evaluation Of Ready To Use Radiopharmaceuticals[1]

This post and the paper it links to were prepared at the instruction of Novartis; it reflects the views of the authors.

European Union Healthcare

AP

Arnold & Porter

Belgian Competition Authority Issues Guidance On Information Exchange Between Pharmaceutical Companies For Combination Therapies

On 10 September 2025, the Belgian Competition Authority (the BCA) published a communication clarifying the conditions under which pharmaceutical companies may exchange information...

Belgium Anti-trust

AO

A&O Shearman

Towards 2030: The EU's Vision For Life Sciences And Food Innovation

A significant development on the pan-European life sciences front, was the July publication by the European Commission (the "Commission") of its long-awaited Life Sciences Strategy.

Ireland Healthcare

AC

Arthur Cox

GVZH Legal & Regulatory Updates - September Issue

Welcome to the third edition of our 2025 Legal & Regulatory Updates, where we bring you the latest developments designed to keep you informed and ahead in a fast-evolving landscape. In this issue, we cover...

GA

GVZH Advocates

The EU Excludes Economic Operators And Restricts The Use Of Medical Devices Originating In The People's Republic Of China

Worldwide Healthcare

BB

Bech-Bruun

European Commission Publishes New Variation Guidelines For Medicines

European Union Healthcare

AP

Arnold & Porter

Reporting A Hospital For Negligence: Practical Guide And Deadlines To Know

Italy Litigation

BI

Boccadutri International Law Firm

Combination Therapies In Belgium: How To Collaborate Without Breaching Competition Law

Belgium Anti-trust

A

Altius

Règlement IA : répartition des compétences entre les autorités nationales

France Healthcare

DA

Delsol Avocats

EU: New Guidance On The Interplay Between Medical Device Regulations And The AI Act

European Union Healthcare

P

Plesner

MITM : Publication Du Décret D'application Des Mesures Introduites Par La LFSS Pour 2024 Relatives À La Lutte Contre Les Pénuries De Médicaments

France Healthcare

DA

Delsol Avocats

Herbert Smith Freehills Kramer Comments For LSIPR On Small Molecule Litigation In The UPC

KL

Herbert Smith Freehills Kramer LLP

Titanium Dioxide: General Court Strikes Down Classification As Human Carcinogen And ECJ Now Confirms

France Healthcare

A

Altius

European Union And United States Agree On Import Tariffs For Pharmaceutical Products

Worldwide International

VB

Van Bael & Bellis

AI And Funds Tokenization: The Regulatory Experiences In Ireland To Date

Ireland Finance

DE

Dillon Eustace

Ireland Finance

AC

Arthur Cox

'Good Jobs' Podcast: Unpacking The Way Forward (Podcast)

Ireland Employment

LS

Lewis Silkin

Matheson Attends 9th Annual European Fund Finance Symposium

Ireland Finance

M

Matheson

10.4 – Paul Falzon Meets Kenneth Abela (Podcast)

Malta Commercial

GA

Ganado Advocates

Publication d'un guide d'implémentation de l'éthique dans les systèmes d'intelligence artificielle en santé

Le 29 juillet 2025, la Délégation au Numérique en Santé (DNS) a publié un guide d'implémentation de l'éthique dans les systèmes d'intelligence...

France Technology

DA

Delsol Avocats

European Patent Attorney – Role, Qualifications & Career Path

Understanding the role and needs of a European Patent Attorney is essential for effective intellectual property (IP) management.

Q

Questel

Pharmaceutical Advertising Laws And Regulations Ireland 2025

The advertising of medicinal products is governed by a combination of legislation and self-regulatory codes of practice.

Ireland Healthcare

AC

Arthur Cox

The New EU "Pharma Package": Interplay With The Critical Medicines Act And Other Shortage Initiatives

In this eighth alert in our weekly series on the EU Pharma Package, we continue our overview of initiatives with respect to security of supply and shortage prevention and mitigation.

European Union Healthcare

CM

Crowell & Moring LLP

A Heart Monitor At The Crossroads Of EU Data, Security And Medical Rules

Malta Healthcare

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GTG

Podcast Series Episode 2: Legal Framework Of Medically Assisted Reproduction In Greece

Greece Healthcare

BL

Bernitsas Law

The New EU "Pharma Package": Access Conditionalities And Shortage Measures – A Comparison Of Commission/Parliament/Council Positions

Belgium Healthcare

CM

Crowell & Moring LLP

Commission Guidelines For Providers Of General-purpose AI Models

European Union Healthcare

AP

Arnold & Porter

Exclusion Of Chinese Medical Devices From Public Procurements

Worldwide Government

P

Plesner

The EU Pharma Package: Status Following The Council's Adoption Of Its General Approach

Denmark Healthcare

P

Plesner

Italian Medical Device Payback: Italy Approves 75% Reduction On Medical Device Payback To End Disputes

Italy Healthcare

AO

A&O Shearman

New Danish Pilot Program With Reimbursement For Certain Medicines Based On A Negotiated Confidential Price

Denmark Healthcare

P

Plesner

The New EU "Pharma Package": The "Bolar" Exemption – A Comparison Of Commission/Parliament/Council Positions

European Union IP

CM

Crowell & Moring LLP

European Biosimilar Updates – Formycon's Ustekinumab And Alvotech's Cetrolizumab Pegol

Germany Healthcare

GP

Goodwin Procter LLP

Italian Medical Device Payback: Italy Approves 75% Reduction On Medical Device Payback To End Disputes

Italy's payback system for medical devices has been a source of significant upheaval in the sector, with both domestic and international companies closely monitoring developments.

Italy Healthcare

AO

A&O Shearman

New Danish Pilot Program With Reimbursement For Certain Medicines Based On A Negotiated Confidential Price

The new pilot program, applicable from 1 July 2025 to 30 June 2028, allows pharmaceutical companies to apply for reimbursement for prescription-only medicines based on a confidential price.

Denmark Healthcare

P

Plesner

The New EU "Pharma Package": The "Bolar" Exemption – A Comparison Of Commission/Parliament/Council Positions

In this sixth alert in our weekly series on the EU Pharma Package, we focus on the proposals of the European Commission, European Parliament and Council of the EU for another topic with a highly debated scope and with diverging interpretations across EU Member States: the "Bolar" exemption.

European Union IP

CM

Crowell & Moring LLP

European Biosimilar Updates – Formycon's Ustekinumab And Alvotech's Cetrolizumab Pegol

On June 26, 2025, Formycon AG ("Formycon") announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH ("Ratiopharm") for the semi-exclusive commercialization...

Germany Healthcare

GP

Goodwin Procter LLP

REACH Obligation To Register Imported Chemicals May Be Assumed By A Person Other Than The Buyer

European Union Healthcare

A

Altius

Economics Weekly Alert 24/2025

Υπενθυμίζουμε τους πελάτες μας για τις προθεσμίες καταβολής των ακόλουθων φόρων

Cyprus Strategy

Ki

KPMG in Cyprus

Medical Devices News - EU Commission Expands The Use Of Electronic Instructions For Use (EIFU)

On 16 July 2025, Commission Implementing Regulation (EU) 2025/1234 will enter into force, amending the existing eIFU Regulation (EU) 2021/2226.

European Union Healthcare

P

Plesner

First Health Apps Recommended By The Danish Board For Health Apps

The Danish Board for Health Apps has recently published its first five recommendations of health apps.

Denmark Healthcare

P

Plesner

EU Consults On New GMP Rules For AI In Pharma Manufacturing

On 7 July 2025, the European Commission launched a public consultation that could mark the start of a turning point for how Artificial Intelligence (AI) is used in pharmaceutical manufacturing.

European Union Technology

AP

Arnold & Porter

L'IA médicale de Microsoft MAI-DxO bouscule la médecine

France Technology

HA

Haas Avocats

Neurotech : Au Coeur De L'esprit, Aux Frontières Du Droit

France Healthcare

HA

Haas Avocats

EU AI Act – Latest Regulatory Developments In Finland

Finland Technology

HS

Hannes Snellman Attorneys Ltd

European Commission Consultation Shapes High-risk AI Classification For Life Sciences In The EU

European Union Healthcare

OC

Osborne Clarke

EU Guidance Details How Technical And Clinical Standards Converge For AI In Medtech

European Union Healthcare

OC

Osborne Clarke

EU Updates Regulation On Electronic Instructions For Medical Devices

European Union Healthcare

P

PLMJ

Review Of A Year Of Administrative Case Law On Market Access

France Healthcare

D

Dechert

Social Security Financing Bill For 2025

France Government

D

Dechert

DPIAs, Clinical Trials And AI: Health Sector And Lifesciences Updates

Ireland Technology

WF

William Fry

Life Sciences Outlook 2025 - Oliver O'Connor, Irish Pharmaceutical Healthcare Association

Ireland Healthcare

AC

Arthur Cox

The New EU Product Liability Directive: Key Changes And Implications For The Life Sciences Sector

Ireland Healthcare

MF

McCann Fitzgerald

Life Sciences Outlook 2025 - Mergers And Acquisitions

Ireland Commercial

AC

Arthur Cox

Life Sciences Outlook 2025 - Environment, Construction And Real Estate

Ireland Real Estate

AC

Arthur Cox

LIfe Sciences Outlook 2025 - ESG And Energy

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Litigation, Dispute Resolution And Products

Ireland Healthcare

AC

Arthur Cox

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Latest Videos

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What Regulatory Challenges Are Facing The Life Sciences Sector? (Video)

WF

William Fry

Webinar Video | Lunch & Learn: Life Sciences : Morceaux Choisis

A

Altius

Webinar Video | Life Sciences Session #2: Vaccine Liability: What If Vaccination Goes Wrong?

A

Altius

Launch Of Our Medical Device Publication (Video)

WF

William Fry

Understanding Sunshine Rules: How New Transparency Regulations In Europe Are Changing Relationships Between Industry And Health Care Professionals (Video)

HL

Hogan Lovells

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