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.

The EU Pharma Package: The Transferable Exclusivity Voucher Compromise Proposal

Addressing antimicrobial resistance (AMR) is one of the key objectives of the EU’s legislative reform. However, the development pipeline for new effective antimicrobials is obstructed, primarily due to a profound market failure: the low commercial value of the antimicrobial medicinal product market (costly development versus naturally limited market). In short, the market alone cannot deliver the solutions urgently needed to address AMR.

European Union Healthcare

CM

Crowell & Moring LLP

CJEU Rules On GDPR Access Rights And Abuse Of Rights: What The Brillen Rottler Judgment Means For Life Sciences Companies

On 19 March 2026, the Court of Justice of the European Union (CJEU or Court) issued its judgment in Case C-526/24, Brillen Rottler GmbH & Co. KG v TC.

Belgium Healthcare

AP

Arnold & Porter

Pricing And Reimbursement Of Medicines In Ireland: New Framework Agreement 2026-2029 Published

Following the announcement in January that agreement had been reached, the full text of the Framework Agreement on the Supply and Pricing of Medicines ("FASPM")...

Ireland Healthcare

AC

Arthur Cox

Getting Ready For The EU Pharma Package Part 2: Stricter Rules On Environmental Risk Assessment – Everything You Need To Know

After the Council and the European Parliament have reached an agreement in the trilogue negotiations on the so-called Pharma Package in December 2025...

European Union Healthcare

AO

A&O Shearman

Non-compliance To The Interoperability, Ethics, And Security Standards May Be Penalized

France Healthcare

DA

Delsol Avocats

For Medical Devices, “Possible Use” Amounts To Infringement Only If The Use Is In Line With Medical Practice

AO

A&O Shearman

Belgium’s Healthcare Plans For 2026 – And Where Pharma Fits In

Belgium Healthcare

A

Altius

La non-conformité aux exigences des référentiels d'interopérabilité, d'éthique et de sécurité désormais sanctionnable

France Healthcare

DA

Delsol Avocats

The EU Pharma Package: Formal Adoption In Sight

European Union Healthcare

CM

Crowell & Moring LLP

The CNIL And The French National Authority For Health Join Forces To Support Digital Health Stakeholders

France Healthcare

DA

Delsol Avocats

La CNIL et la HAS s’associent pour accompagner les acteurs du numérique en santé

France Technology

DA

Delsol Avocats

Getting Ready For The EU Pharma Package: Key Changes To Regulatory Exclusivities, Orphan Medicinal Products And The “Bolar” Exemption Provisions

European Union Healthcare

AO

A&O Shearman

Movement On The Pharma Package: Formal Adoption Within Reach

Ireland Healthcare

AC

Arthur Cox

Greece’s New Ministerial Decision On Clinical Trial Contracts: Standardization, Timelines And E-signatures

Greece Healthcare

BL

Bernitsas Law

EU Unveils 20th Package Of Sanctions Against Russia

European Union International

MK

Michael Kyprianou Law Firm

Asset Management & Investment Funds Update - January 2026

Ireland Finance

WF

William Fry

The Italian Market: Gaming & Regulation (Podcast)

Italy Media & IT

WP

WH Partners

Netherlands Introduces 36% Tax On Unrealised Gains – Why A Cyprus Company Is A Strategic Alternative

Nikita & Partners Limited

Luxembourg Retail Fund Can Now Have Crypto Exposure - And What About Swiss Funds?

Luxembourg Technology

LL

Loyens & Loeff

Life Sciences: Update On National Strategy; Framework Agreements On Pricing And Supply Of Medicines

October 2025's consultation by the Department of Enterprise, Tourism and Employment (DETE) on shaping Ireland's planned new National Life Sciences Strategy...

Ireland Healthcare

MF

McCann Fitzgerald

Professional Associations Under The Health Care Professions Act

This article examines the requirements an organisation must meet to be recognised as a professional association under the Health Care Professions Act, Chapter 464 of the Laws of Malta, together with the obligations imposed on such associations ...

Malta Healthcare

GA

Ganado Advocates

NIS2 Implementation Enacted - Complete Guide

The Directive on measures for a high common level of cybersecurity across the Union (NIS2 -2022/2555) entered into force in January 2023.

Poland Technology

KL

Kobylanska Lewoszewski Mednis sp. j.

Clinical Trials Regulation In Ireland And The EU: Key Updates Shaping 2025 And 2026

2025 saw a continuous and re-invigorated focus on the regulation of clinical trials in Ireland and the EU. This briefing looks at what has been happening in this space and what is set to come.

European Union Healthcare

AC

Arthur Cox

The CNIL's Economic Analysis Unit Unveils Its 2026–2028 Work Programme

France Healthcare

DA

Delsol Avocats

UPC Structure – Local, Regional And Central Divisions And Court Of Appeal, Judges & Languages

KL

Herbert Smith Freehills Kramer LLP

EU Critical Medicines Act: What Life Sciences Companies Need To Know

Ireland Healthcare

MF

McCann Fitzgerald

EHDS Regulation: Secondary Use Of Electronic Health Data

Ireland Healthcare

MF

McCann Fitzgerald

AGCOM Adopts New Age Verification Mechanisms For Websites And VSPS Disseminating Adult Content

Italy Healthcare

GA

Global Advertising Lawyers Alliance (GALA)

The European Accessibility Act As Implemented In Italy: What's New For Online Pharmacies?

Italy Healthcare

GA

Global Advertising Lawyers Alliance (GALA)

The UPC's Emerging Approach To Injunctions: Patterns, Pitfalls, And Global Implications

SR

McDermott Will & Schulte

EU Agrees Landmark Reform Of Pharmaceutical Legislation

Ireland Healthcare

MF

McCann Fitzgerald

Turning Europe Into A Biotech Powerhouse: Commission Unveils Biotech Act And Regulatory Simplification For Devices

Ireland Healthcare

MF

McCann Fitzgerald

Charting Ireland's Life Sciences Strategy: Scope And Policy Priorities

Ireland Healthcare

MF

McCann Fitzgerald

The UPC's Emerging Approach To Injunctions: Patterns, Pitfalls, And Global Implications

Since its entry into force on June 1, 2023, the Unified Patent Court (UPC) has seen a growing number of cases across various fields, including pharmaceuticals, biotechnology...

SR

McDermott Will & Schulte

EU Agrees Landmark Reform Of Pharmaceutical Legislation

A new pharmaceutical package, which aims to overhaul, modernise and streamline the EU's existing legal framework for the pharmaceutical sector, was agreed between the EU Council...

Ireland Healthcare

MF

McCann Fitzgerald

Turning Europe Into A Biotech Powerhouse: Commission Unveils Biotech Act And Regulatory Simplification For Devices

This week's package of health sector-focused measures from the European Commission contains a number of flagship deliverables under the July 2025 EU Life Sciences Strategy...

Ireland Healthcare

MF

McCann Fitzgerald

Charting Ireland's Life Sciences Strategy: Scope And Policy Priorities

In a pivotal moment for a sector that employs around 100,000 people in Ireland and delivers close to €100 billion in exports annually, the Department of Enterprise...

Ireland Healthcare

MF

McCann Fitzgerald

Clinical Trials Reform: Ireland's Blueprint For Transforming The Clinical Trials Landscape

Ireland Healthcare

MF

McCann Fitzgerald

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

The EU Commission has published its 170-page proposal on revisions of the Medical Device Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Regulation (EU)...

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

How Germany's Chemical And Pharmaceutical Industry Is Competing Globally

AM

Alvarez & Marsal

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

European Union Healthcare

MB

Mayer Brown

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

Cyprus Technology

E

Eurofast

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

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

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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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