Ireland: Life Sciences, Biotechnology & Nanotechnology

Subscribe

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.

A New Regulatory Landscape For Veterinary Manufacturers

Since July 2026, veterinary medicines manufacturers have been subject to restructured good manufacturing practice (GMP) rules under two new EU Regulations. These standalone frameworks introduce mandatory quality obligations for finished products and active substances, replacing previous guidance-based requirements with directly applicable law. Meanwhile, the European Commission's proposed Biotech Act I aims to streamline variation procedures, simplify GMO approvals, and introduce new incentives for biotechn

European Union Healthcare

AC

Arthur Cox

EU Council Adopts New EU Pharma Package

The Council of the EU has adopted the most comprehensive reform of EU pharmaceutical legislation in over 20 years, fundamentally reshaping regulatory protection mechanisms, market exclusivity periods, and incentive structures for pharmaceutical companies. These reforms balance patient access to medicines with creating a more competitive and innovation-friendly environment, addressing antimicrobial resistance, medicine supply challenges, and the early availability of generic alternatives.

Ireland Healthcare

M

Matheson

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

AC

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

AC

Arthur Cox

Life Sciences Outlook 2026 - Pharma Regulatory And Compliance

European Union Government

AC

Arthur Cox

Life Sciences Outlook 2026 - Data And Digital

European Union Government

AC

Arthur Cox

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

European Union Healthcare

AC

Arthur Cox

European Medicines Agency SME Status – A Quick Guide

Ireland Healthcare

AC

Arthur Cox

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

Ireland Technology

WF

William Fry

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

Ireland Healthcare

AC

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

M

Matheson

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

Ireland Healthcare

AC

Arthur Cox

Movement On The Pharma Package: Formal Adoption Within Reach

Ireland Healthcare

AC

Arthur Cox

The Data Act – “Access By Design” Requirement Comes Into Force

Ireland Privacy

M

Matheson

EU KIDS Act: Grown-Up Rules For Online Providers

European Union Media & IT

WF

William Fry

Ireland Update: The Cyber Resilience Act

Ireland Technology

MG

Maples Group

Ireland's Domestic AI Legislation Comes Into Force

Ireland Technology

AC

Arthur Cox

Corporate Update August 2026 - Sustainability Reporting & ESG

Ireland Commercial

AC

Arthur Cox

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

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

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

MF

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

MF

McCann Fitzgerald

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

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

AC

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

AC

Arthur Cox

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

Ireland Consumer

AC

Arthur Cox

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

Ireland Healthcare

AC

Arthur Cox

EU Pharma Package: Agreement Reached

European Union Healthcare

AC

Arthur Cox

What's Another Year 2026 - Life Sciences

The long-awaited revision of the EU pharmaceutical legislation has reached a significant milestone: agreement was secured on 11 December 2025 at the trilogue stage...

European Union Healthcare

AC

Arthur Cox

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

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

AC

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

AC

Arthur Cox

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

Ireland Healthcare

AC

Arthur Cox

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

We talk to Oliver O'Connor, CEO, Irish Pharmaceutical Healthcare Association, about his role, his career journey and his views on some key issues faced by the industry.

Ireland Healthcare

AC

Arthur Cox

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

The new Product Liability Directive marks the most significant overhaul of product liability law in nearly four decades.

Ireland Healthcare

MF

McCann Fitzgerald

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

AC

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

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

LIfe Sciences Outlook 2025 - Interview

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Regulatory And Compliance

Ireland Healthcare

AC

Arthur Cox

LIfe Sciences Outlook 2025 - Introduction

Ireland Healthcare

AC

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

AC

Arthur Cox

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

Ireland Healthcare

RL

RDJ LLP

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

Ireland Healthcare

AC

Arthur Cox

Irish FDI Screening Regime – Application To The Life Sciences Sector

Ireland Healthcare

M

Matheson

EU Medical Devices – Current Developments

Ireland Healthcare

AC

Arthur Cox

Irish Pharmaceutical Healthcare Association: Revised Code Effective 1 June 2025

Ireland Healthcare

AC

Arthur Cox

European Commission Proposes Critical Medicines Act

Ireland Healthcare

WF

William Fry

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

Ireland Healthcare

WF

William Fry

See more

Latest Videos

See more

Life Sciences Outlook 2026 - Mergers And Acquisitions (Video)

AC

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

Mondaq uses cookies on this website. By using our website you agree to our use of cookies as set out in our Privacy Policy.

Learn More