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.

How Germany's Chemical And Pharmaceutical Industry Is Competing Globally

The chemical and pharmaceutical industry in Germany is undergoing a profound shift. Competitive pressure from Asia continues to intensify, regulatory demands are rising, and long-established innovation models are proving less effective under current market conditions.

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Alvarez & Marsal

Europe's Pharma Reform: How The Discussion Affects Strategic Decisions Today

The EU's pharmaceutical reform package represents the most comprehensive overhaul of the bloc's medicines framework in two decades

European Union Healthcare

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Mayer Brown

The Rise Of Living Intelligence: How Autonomous Systems Are Transforming Global Business In 2025

In 2025, the world has entered a new technological era, one defined not just by digital innovation, but by the emergence of living intelligence. This new category of autonomous systems...

Cyprus Technology

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Eurofast

Update To The Pharmacovigilance Legislative Framework – What Do Marketing Authorisation Holders Need To Know?

Pharmacovigilance plays a crucial role in ensuring the continued safety and effectiveness of medicines. It involves the monitoring and evaluation...

Ireland Healthcare

AC

Arthur Cox

Key Reforms Introduced By The Law 5243/2025 Aimed At Modernizing The Public Healthcare System And Healthcare Services

Greece Healthcare

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Bernitsas Law

French Competition Authority—for The First Time—sanctions Below-threshold Deal Under Abuse Of Dominance Provisions

France Anti-trust

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A&O Shearman

Fuller Lips And Failed Promises: When Cosmetic Surgery Meets The Courtroom

Cyprus Litigation

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Elias Neocleous & Co LLC

General Court Of EU Judgement On Case T-483/22: Marketing Authorizations And Granting Of Regulatory Advantages

Greece Healthcare

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Bernitsas Law

Belgian Constitutional Court Strikes Down Pharma Industry 'Unavailability Contribution'

Belgium Healthcare

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Altius

IP Biotechnology: Protecting Innovation In The Biotech Industry

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Questel

LD Hamburg, October 21, 2025, Order In The Proceedings For Provisional Measures, UPC_CFI_553/2025

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Bardehle Pagenberg

App Stores May Be Subject To EU Medical Device Regulatory Frameworks

Ireland Healthcare

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Matheson

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

European Union Healthcare

AP

Arnold & Porter

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

Belgium Anti-trust

AO

A&O Shearman

#Cyprus #Brokers #License & #Compliance #Services By #CYAUSE #icara #correp #stp #marketmakers #pii (Video)

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CYAUSE Audit Services Ltd

EUDR Update: One-year Delay Cancelled As EU Proposes New 'Targeted' Simplification Measures – What Does This Mean For Businesses?

Belgium Commercial

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Fieldfisher

Podcast Episode 1: Cross-Border Disputes In The EU: The Cyprus Advantage (Podcast)

Cyprus Technology

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AGPLAW | A.G. Paphitis & Co. LLC

Podcast Series Episode 8: Multiple-Vote Share Structures Directive

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Bernitsas Law

E-commerce : Les Enjeux Juridiques Pour Préparer 2026 (Video)

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Haas Avocats

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...

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GVZH Advocates

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

The EU adopts rules restricting the access of economic operators and the use of medical devices originating in the People's Republic of China to the EU public procurement market.

Worldwide Healthcare

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Bech-Bruun

European Commission Publishes New Variation Guidelines For Medicines

The European Commission has published new Guidelines on the details of the various categories of variations (to the terms of marketing authorisations ("MA") for medicinal products) ("Variations Guidelines").

European Union Healthcare

AP

Arnold & Porter

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

Italy Litigation

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Boccadutri International Law Firm

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

Belgium Anti-trust

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Altius

Règlement IA : répartition des compétences entre les autorités nationales

France Healthcare

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Delsol Avocats

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

European Union Healthcare

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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

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Delsol Avocats

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

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Herbert Smith Freehills Kramer LLP

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

France Healthcare

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Altius

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

Worldwide International

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Van Bael & Bellis

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

France Technology

DA

Delsol Avocats

European Patent Attorney – Role, Qualifications & Career Path

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Questel

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

The European Commission often relies on scientific evidence for its regulatory decisions. But when challenged, how much deference is owed to the regulator's interpretation of the underlying science?

France Healthcare

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Altius

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

On 21 August 2025, the European Union and the United States published a Joint Statement (JS) "on a United States-European framework on an agreement on reciprocal...

Worldwide International

VB

Van Bael & Bellis

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.

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Questel

Pharmaceutical Advertising Laws And Regulations Ireland 2025

Ireland Healthcare

AC

Arthur Cox

Commission Guidelines For Providers Of General-purpose AI Models

On July 18, 2025, the European Commission released its guidelines on the obligations for providers of general-purpose AI (GPAI) models under the European Union's AI Act.

European Union Healthcare

AP

Arnold & Porter

Exclusion Of Chinese Medical Devices From Public Procurements

The European Commission has adopted its first-ever measure under the International Procurement Instrument prohibiting contracting authorities from procuring medical devices originating from China...

Worldwide Government

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Plesner

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

On 4 June 2025, the Council of the European Union adopted its general approach to the proposed reform of the EU pharmaceutical legislation (the Pharma Package).

Denmark Healthcare

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Plesner

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

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A&O Shearman

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

Denmark Healthcare

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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

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Goodwin Procter LLP

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

European Union Healthcare

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Altius

Updates To The EU Pharmacovigilance Rules: Key Takeaways For Marketing Authorisation Holders

European Union Healthcare

AP

Arnold & Porter

The New EU "Pharma Package": Global (Orphan) Marketing Authorization

European Union Healthcare

CM

Crowell & Moring LLP

EU Confirms App Stores And Developers Are Subject To Medical Device Laws

European Union Healthcare

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Osborne Clarke

Nordic-Baltic Regional Division, July 21, 2025, Decision In First Instance, UPC_CFI_380/2023

BP

Bardehle Pagenberg

Economics Weekly Alert 24/2025

Cyprus Strategy

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KPMG in Cyprus

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

European Union Healthcare

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Plesner

First Health Apps Recommended By The Danish Board For Health Apps

Denmark Healthcare

P

Plesner

EU Consults On New GMP Rules For AI In Pharma Manufacturing

European Union Technology

AP

Arnold & Porter

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

France Technology

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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

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Hannes Snellman Attorneys Ltd

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Latest Videos

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

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William Fry

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

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Altius

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

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Altius

Launch Of Our Medical Device Publication (Video)

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William Fry

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

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Hogan Lovells

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