News & Analysis as of

Life Sciences Regulatory Reform United Kingdom

Hogan Lovells

Key takeaways – UK MHRA’s response to consultation on ‘Medical Devices Regulations: Routes to market and in vitro diagnostic...

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published its responses to the consultation on Medical Device Regulations: Routes to market and in vitro diagnostic devices carried out last year....more

Morgan Lewis

UK Life Sciences Sector Plan: What In-House Legal and Compliance Teams Need to Know

Morgan Lewis on

The UK government recently unveiled its 10-year Life Sciences Sector Plan, putting forward a comprehensive strategy for transforming the UK into a global leader in life sciences by 2035. This LawFlash outlines key areas of...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Third Quarter of 2025 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more

Morgan Lewis - As Prescribed

New Measures to Encourage Clinical Trials in the United Kingdom

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...more

Ropes & Gray LLP

New Horizons: Implications of the UK-India Trade Agreement for Life Sciences and Innovation

Ropes & Gray LLP on

The UK and India have announced one of the “biggest and most economically significant” bilateral trade agreements the UK has signed since Brexit, following years of discussions. This marks a significant milestone for the UK...more

A&O Shearman

A new approach to regulation by the MHRA and NICE

A&O Shearman on

On March 17, 2025, the government published a policy paper with an Action Plan for regulation and regulators, outlining how it intends to reform the UK's regulatory system to support growth and innovation. The Action Plan...more

McDermott Will & Schulte

MHRA Updates its Timeline for Medical Device Regulatory Changes in the UK

McDermott Will & Schulte on

The MHRA recently published an update on its plans for MedTech regulatory change. The update confirmed that the new framework will be introduced through four statutory instruments to update and replace the UK Medical Devices...more

Akin Gump Strauss Hauer & Feld LLP

Akin Intelligence - March 2024

Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q2 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

A&O Shearman

Clinical Trial Regulation: A streamlined reform of the UK Clinical Trials Regulatory Framework - new measures published

A&O Shearman on

The MHRA announced on Tuesday the biggest overhaul of clinical trial regulation in the UK in 20 years. The details of the amendments to clinical trial regulation are set out in the MHRA’s response to a public consultation...more

Hogan Lovells

UK regulation of medical devices from 1 January 2021

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published new guidance (the "Guidance") on how medical devices will be regulated in Great Britain ("GB") (England, Wales and Scotland) and in Northern...more

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