Ireland: 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.

Life Sciences Outlook 2026

Arthur Cox's Life Sciences Outlook 2026 examines critical regulatory developments and strategic opportunities shaping Ireland's life sciences sector. The publication explores Ireland's EU Council Presidency and its potential impact on advancing key legislative initiatives including the Biotech Act I and medical device reforms. Industry leaders will find comprehensive analysis spanning pharmaceutical compliance, medtech regulation, data governance, M&A activity, and environmental considerations.

Ireland Healthcare

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Arthur Cox

Life Sciences Outlook 2026 - Mergers And Acquisitions (Video)

Explore how modern workplace design and professional environments are evolving to meet contemporary business needs. Discover insights into creating functional, aesthetically pleasing spaces that enhance productivity and reflect organizational values.

Ireland Strategy

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Arthur Cox

Life Sciences Outlook 2026 - Pharma Regulatory And Compliance

The EU continues its ambitious reform agenda for life sciences regulation, with landmark agreements on pharmaceutical legislation and biotech innovation frameworks. Ireland's Council Presidency is set to drive progress on critical medicines legislation and medical device reforms, while new investment initiatives aim to mobilize billions into Europe's biotech sector.

European Union Government

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Arthur Cox

Life Sciences Outlook 2026 - Data And Digital

The European Union's evolving regulatory landscape for artificial intelligence, cybersecurity, and health data is creating new compliance challenges and opportunities for life sciences organizations. From the AI Act's refinements to the delayed NIS2 Directive transposition in Ireland, stakeholders must navigate multiple intersecting frameworks while preparing for the European Health Data Space Regulation's implementation.

European Union Government

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Arthur Cox

Bridging The Gap: An Insight Into Europe’s Biotech Proposals

European Union Healthcare

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Arthur Cox

European Medicines Agency SME Status – A Quick Guide

Ireland Healthcare

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Arthur Cox

EU AI Act Omnibus Deal Reached: Postponed Deadlines, Watermarking Compromise, And The Nudificiation Prohibition

Ireland Technology

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William Fry

Life Sciences And Healthcare M&A 2025: A Year In Review

Ireland Healthcare

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Arthur Cox

NIS 2 – A New Era For The Life Sciences Sector

Ireland Technology

M

Matheson

EDPB Publishes Draft Guidelines On Processing Of Personal Data For Scientific Research Purposes

Ireland Privacy

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Matheson

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

Ireland Healthcare

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Arthur Cox

Movement On The Pharma Package: Formal Adoption Within Reach

Ireland Healthcare

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Arthur Cox

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

Ireland Healthcare

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McCann Fitzgerald

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

European Union Healthcare

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Arthur Cox

The EU 28th Regime: What Businesses Need To Know About ‘EU Inc.”

Ireland Commercial

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Matheson

Authorisation Processes In Ireland (Podcast)

Ireland Finance

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Arthur Cox

Behind The Scenes Of Ireland’s EU Presidency: Insights From Rory Montgomery (Podcast)

M

Matheson

From Copilot To Colleague: How Agentic AI Is Reshaping Work, Governance And Risk (Podcast)

Ireland Technology

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William Fry

AI Survey 2025 - AI Adoption Trends

Ireland Technology

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Arthur Cox

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

MEPs agreed the European Parliament's negotiating position on the planned EU Critical Medicines Act (EU CMA) this week (20 January 2026), clearing the way for trilogue negotiations.

Ireland Healthcare

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McCann Fitzgerald

EHDS Regulation: Secondary Use Of Electronic Health Data

As part of the EU's Data Strategy, the European Health Data Space Regulation is intended to bring about greater reuse of electronic health data for research, innovation and policy-making purposes.

Ireland Healthcare

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McCann Fitzgerald

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

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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

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McCann Fitzgerald

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

Ireland Healthcare

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McCann Fitzgerald

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

Ireland Healthcare

MF

McCann Fitzgerald

Advertising And Labelling Of Medicinal Products On Social Media

Ireland Healthcare

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Arthur Cox

EU Reaches Agreement On ‘Pharma Package’ Legislative Reforms

Ireland Anti-trust

M

Matheson

What's Another Year 2026 - Life Sciences

European Union Healthcare

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Arthur Cox

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

Ireland Consumer

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Arthur Cox

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

Ireland Healthcare

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Arthur Cox

EU Pharma Package: Agreement Reached

European Union Healthcare

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Arthur Cox

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

Ireland Healthcare

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Arthur Cox

App Stores May Be Subject To EU Medical Device Regulatory Frameworks

Ireland Healthcare

M

Matheson

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

In a joint press conference on 16 December, Commissioners Várhelyi (Commissioner for Health and Animal Welfare) and Dombrovskis (Commissioner for Economy and Productivity...

Ireland Healthcare

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Arthur Cox

EU Pharma Package: Agreement Reached

The long-awaited revision of the EU pharmaceutical legislation has reached a significant milestone: agreement has been secured at the trilogue stage between...

European Union Healthcare

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Arthur Cox

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

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Arthur Cox

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

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

Ireland Healthcare

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Arthur Cox

Life Sciences Outlook 2025 - Mergers And Acquisitions

This article provides an overview of M&A activity in the healthcare and life sciences sector during 2024 and the outlook for 2025.

Ireland Commercial

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Arthur Cox

Life Sciences Outlook 2025 - Environment, Construction And Real Estate

The pathway to developing and operating pharmaceutical infrastructure in Ireland is complex. Planning permission granted by the planning authority or An Bord Pleanála ("ABP") and licences issued...

Ireland Real Estate

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Arthur Cox

LIfe Sciences Outlook 2025 - ESG And Energy

Ireland's National Energy Demand Strategy outlines regulatory decisions around smart energy services and customer demand flexibility and response.

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Litigation, Dispute Resolution And Products

It is fair to say that the last number of years have seen a shift in terms of the shape of the liability regime for the life sciences industry, as well as industry more broadly.

Ireland Healthcare

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Arthur Cox

LIfe Sciences Outlook 2025 - Interview

Ireland Healthcare

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Arthur Cox

LIfe Sciences Outlook 2025 - Regulatory And Compliance

Ireland Healthcare

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Arthur Cox

LIfe Sciences Outlook 2025 - Introduction

Ireland Healthcare

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Arthur Cox

Data And AI In Medicines Regulation: EMA And HMA Work Plan

Ireland Healthcare

WF

William Fry

Commission Revamps MIR Form For MDR And IVDR Compliance

Ireland Healthcare

WF

William Fry

EU Pharma Package: Trilogue Negotiations Commence

Ireland Healthcare

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Arthur Cox

A New Lease Of Life For Organ Donation Regulation - The Human Tissue Act Becomes Law

Ireland Healthcare

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RDJ LLP

Telemedicine And The Advanced Practice Of Medicine: An Irish Regulatory Perspective

Ireland Healthcare

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Arthur Cox

Irish FDI Screening Regime – Application To The Life Sciences Sector

Ireland Healthcare

M

Matheson

EU Medical Devices – Current Developments

Ireland Healthcare

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Arthur Cox

Irish Pharmaceutical Healthcare Association: Revised Code Effective 1 June 2025

Ireland Healthcare

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Arthur Cox

European Commission Proposes Critical Medicines Act

Ireland Healthcare

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William Fry

Sector Watch: Pharma, Medical & Biotech In Ireland's M&A Market

Ireland Healthcare

WF

William Fry

The European Health Data Space Regulation – What Digitalising EU Health Data Means For Industry

European Union Healthcare

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Arthur Cox

Ireland's Programme For Government 2025: The Life Sciences And Healthcare Lens

Ireland Healthcare

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Arthur Cox

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Latest Videos

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Life Sciences Outlook 2026 - Mergers And Acquisitions (Video)

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Arthur Cox

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

WF

William Fry

Launch Of Our Medical Device Publication (Video)

WF

William Fry

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