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.

Preliminary Questions On Article 10b Of The Medicinal Products Directive: A Gamechanger For The Admission Of Combination Medicines To The European Market?

On 24 December 2025, the Administrative Jurisdiction Division of the Council of State (Afdeling bestuursrechtspraak Raad van State, ABRvS) referred preliminary questions to the Court of Justice...

European Union Healthcare

LL

Loyens & Loeff

European Commission Proposes Biotech Act To Boost Health Biotechnology In The EU

The Biotech Act aims to help Europe in its struggle to translate world-class life sciences research into commercial success by tackling the structural barriers that have driven start-ups abroad...

Belgium Healthcare

CM

Crowell & Moring LLP

European Regulation: What Does Implementing Regulation (EU) 2025/1466 Mean For Pharmaceutical Companies?

Are your pharmacovigilance operations ready to meet the latest European standards?

European Union Healthcare

UA

UGGC Avocats

Evolving Product Liability And Safety Landscape: Recent And Upcoming Regulatory Developments

The EU and UK have recently introduced several legislative changes which update the existing statutory regime on product liability and safety.

Ireland Consumer

AC

Arthur Cox

EU Commission Proposes Much Anticipated MDR And IVDR Revision

Germany Healthcare

AO

A&O Shearman

Publication du décret sur les professions libérales réglementées de santé

France Healthcare

DA

Delsol Avocats

Green Light – Health Package & Food And Feed Package Adopted By European Commission

Ireland Healthcare

AC

Arthur Cox

EU Reaches Pharma Package Deal: Key Changes At A Glance

Belgium Healthcare

A

Altius

The New EU "Pharma Package:" EU Reaches Landmark Deal On Pharma Package

European Union Healthcare

CM

Crowell & Moring LLP

Paquet pharmaceutique – Accord au niveau de l'UE sur une réforme majeure du secteur pharmaceutique

France Healthcare

AD

August Debouzy

Pharma Package – Deal At The EU Level On A Major Pharma Reform

AD

August Debouzy

EU Pharma Package: Agreement Reached

European Union Healthcare

AC

Arthur Cox

European Institutions Agree On The Reform To The EU Regulatory Framework For Medicinal Products

European Union Healthcare

AP

Arnold & Porter

Vente en ligne de médicaments vétérinaires : publication de l'arrêté fixant les règles techniques applicables aux sites de vente en ligne de médicaments vétérinaires

France Healthcare

DA

Delsol Avocats

LexisNexis France – Financial Responsibility Of Public Officials: 3 Years After The 2022 Reform, What Is The Assessment? (Video)

France Litigation

UA

UGGC Avocats

The Supporting Team Behind Malta's Trusted Corporate Services Provider (Video)

Malta Commercial

CG

CSB Group

The Italian Market: Gaming & Regulation (Podcast)

Italy Media & IT

WP

WH Partners

The EU Pay Transparency Directive (Video) (Podcast)

Ireland Employment

AC

Arthur Cox

Employment Law And Pay Transparency | Remuneration Essentials (Video)

Luxembourg Employment

AM

Arendt & Medernach

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.

AM

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

MB

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

E

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

BL

Bernitsas Law

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

France Anti-trust

AO

A&O Shearman

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

Cyprus Litigation

EN

Elias Neocleous & Co LLC

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

Greece Healthcare

BL

Bernitsas Law

Belgian Constitutional Court Strikes Down Pharma Industry 'Unavailability Contribution'

Belgium Healthcare

A

Altius

IP Biotechnology: Protecting Innovation In The Biotech Industry

Q

Questel

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

BP

Bardehle Pagenberg

App Stores May Be Subject To EU Medical Device Regulatory Frameworks

Ireland Healthcare

M

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

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

To establish jurisdiction, at least the plausible allegation of infringing acts in the country in question is necessary.

BP

Bardehle Pagenberg

App Stores May Be Subject To EU Medical Device Regulatory Frameworks

In June this year, the EU regulatory framework for medical device software saw the adoption of two significant Medical Device Coordination Group guidelines (i) MDCG 2019-11; and (ii) MDCG 2025-4.

Ireland Healthcare

M

Matheson

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

Ireland Healthcare

AC

Arthur Cox

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

As the landscape of modern medicine evolves, combination therapies—those that use two or more distinct medicines, often from different companies...

Belgium Anti-trust

A

Altius

Règlement IA : répartition des compétences entre les autorités nationales

Le 9 septembre dernier, conformément au Règlement sur l'intelligence artificielle (« RIA »), le Ministère de l'économie et des finances a dévoilé la liste des autorités nationales compétentes...

France Healthcare

DA

Delsol Avocats

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

The Medical Device Coordination Group ("MDCG") has recently published guidance on the interplay between the AI Act and the MDR/IVDR.

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

Le 5 août 2025, a été publié au Journal officiel le Décret n°2025-760 du 4 août 2025, qui fixe perses modalités d'application de la loi n°2023-1250 du 26 décembre...

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

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

Q

Questel

Pharmaceutical Advertising Laws And Regulations Ireland 2025

Ireland Healthcare

AC

Arthur Cox

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

European Union Healthcare

CM

Crowell & Moring LLP

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

Malta Healthcare

G

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

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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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