News & Analysis as of

United Kingdom Life Sciences

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

McDermott Will & Emery

What ICO guidance on anonymisation means for health and life sciences companies

What new guidance on anonymisation from the UK Information Commissioner’s Office (ICO) means for healthcare and life sciences companies....more

A&O Shearman

UK will permanently retain its UK+ exhaustion regime to allow continued supply of medicines into the UK

A&O Shearman on

The government has published its response to the consultation on the exhaustion regime for IP rights. The overall conclusion is that the UK will permanently maintain its UK+ IP exhaustion regime, the bespoke (and...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

IR Global

£13.9bn of R&D funding

IR Global on

The UK government has announced a record-breaking £13.9 billion in research and development (R&D) funding for the coming year. This major investment is designed to drive innovation, create quality jobs, and support long-term...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

A&O Shearman

Will Labour’s policy prescription create a stronger UK life sciences sector?

A&O Shearman on

The UK government plans to turbocharge the life sciences sector using policy levers to enhance research and development, innovation hubs, and private fundraising. In this piece, Michael Bloch explores how refinements to...more

Goodwin

Antitrust and Competition Life Sciences Year in Review 2024

Goodwin on

The last year (and particularly the last few months) of the Biden Administration brought a flurry of activity from the Federal Trade Commission (FTC) in the life sciences space, continuing a yearslong pattern of close...more

Goodwin

UK’s MHRA Grants Marketing Authorization for Chikungunya Vaccine

Goodwin on

On February 5, 2025 Valneva SE (“Valneva”) announced that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorization for Valneva’s chikungunya vaccine, IXCHIQ. ...more

A&O Shearman

UPC Court of Appeal confirms strict approach to correcting patent errors by interpretation

A&O Shearman on

Alexion Pharmaceuticals v Amgen (UPC_Coa-405/2024) and Alexion Pharmaceuticals v Samsung Bioepis NL BV (UPC_CoA-402/2024); December 20, 2024. The UPC Court of Appeal has confirmed a strict approach to correcting erroneous...more

Hogan Lovells

MHRA publishes guidance on to new UK medical device post-market surveillance requirements

Hogan Lovells on

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a suite of guidance specifically designed to help medical device manufacturers understand and prepare for the new post-market surveillance (“PMS”)...more

Hogan Lovells

Updated roadmap for UK medical device reforms published by the MHRA

Hogan Lovells on

On 11 December 2024, the MHRA published a revised roadmap for the long-awaited reforms to the UK Medical Device Regulations 2002 (MDR Roadmap). The updated MDR Roadmap provides additional clarity for industry on the intended...more

Hogan Lovells

MHRA confirms five technologies selected for AI Airlock Pilot

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has announced the five technologies selected to participate in the ‘AI Airlock Pilot’ for AI-powered medical devices. The pilot is a regulatory “sandbox” for...more

Hogan Lovells

Framework amending the UK clinical trial regulations laid before Parliament

Hogan Lovells on

On 12 December 2024 the statutory instrument to amend the Medicines for Human Use (Clinical Trials) Regulations 2004 (UK CTR) was laid before Parliament. The Medicines and Healthcare products Regulatory Agency (MHRA),...more

Hogan Lovells

JPM2025: AI integration into UK’s MHRA’s processes presents opportunities, and challenges for regulating medicinal product...

Hogan Lovells on

Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more

Hogan Lovells

MHRA opens consultation on future routes to market and IVDs under the UK medical device regulations

Hogan Lovells on

The MHRA has opened a consultation on proposed future pre-market requirements for medical devices and in vitro diagnostic devices (IVDs) in Great Britain. The consultation expands on proposals considered in the MHRA’s 2021...more

Hogan Lovells

Regulation for medicines manufactured at the point of care introduced before UK Parliament

Hogan Lovells on

The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more

Hogan Lovells

Getting to the point (of care): regulation for medicines manufactured at the point of care introduced before UK Parliament

Hogan Lovells on

The UK's Medicines and Healthcare products Regulatory Agency ("MHRA") has announced first-of-its-kind legislation to better facilitate the manufacture and delivery to patients of medicines that are manufactured at or near the...more

Faegre Drinker Biddle & Reath LLP

The UK Cyber Security and Resilience Bill

The UK government has recently announced that it plans to introduce a Cyber Security and Resilience Bill (Bill). The Bill seeks to update the 2018 Network and Information Security Regulations, which implemented the European...more

McDermott Will & Emery

Private Markets Update | Summer 2024

McDermott Will & Emery on

The Private Markets Update highlights key developments emerging from private markets across Europe, the UK and the United States, exploring the cross-border issues that matter to investors and sponsors in alternative assets. ...more

McDermott Will & Emery

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

McDermott Will & Emery 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

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 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....more

Hogan Lovells

UK MHRA publishes blueprint for the international recognition of medical devices

Hogan Lovells on

The UK Medicines and Healthcare products Regulatory Agency (MHRA's) has published a Statement of policy intent: international recognition of medical devices outlining its proposal for the International Recognition Procedure...more

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