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United Kingdom Regulatory Agenda Life Sciences

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

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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

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

McDermott Will & Emery

International News: Spotlight on Foreign Investment

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In this dynamic global landscape, investors have always been required to make savvy, smart choices. This requires navigating through the intricate web of bilateral treaty protection, exploring the vital role these agreements...more

McDermott Will & Emery

Lowest-risk Clinical Trials Will Benefit From a New Notification Scheme and a Shorter Period for Application Processing

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On 12 October 2023, the Medicines and Healthcare products Regulatory Agency (the MHRA) announced that the healthcare and life sciences sector will benefit from a new streamlined notification scheme for lowest-risk clinical...more

McDermott Will & Emery

Investing in Healthcare & Life Sciences - An International Guide to Regulatory and Transactional Issues Across the Sector -...

McDermott Will & Emery on

As macroeconomic forces and geopolitical dynamics continue to shape the M&A and investment climate globally, health and life sciences transactions continue to remain high priority sectors presenting both high growth and...more

McDermott Will & Emery

Great Britain and European Union Timelines: What Are the Key Dates for Transition?

The Medicines and Healthcare products Regulatory Agency (MHRA) recently published long-awaited guidance confirming that there will be a delay in the implementation of new legislation for the Great Britain market and an...more

McDermott Will & Emery

Health Data in the EU and UK – Regulatory Trends and Developments

In light of the increasing number of enforcement incidents under the General Data Protection Regulation (GDPR), organisations active in the Health and Life Sciences sectors in the United Kingdom, the European Union (EU) and...more

McDermott Will & Emery

Special Report: Developments in UK Life Sciences – Spring Update 2022

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MHRA LAUNCHES UK CLINICAL TRIAL REGULATION CONSULTATION - The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom),...more

McDermott Will & Emery

MHRA Launches UK Clinical Trial Regulation Consultation

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The UK Government, through the Medicines and Healthcare Products Regulatory Agency (MHRA) (the medicines and medical device regulator in the United Kingdom), recently announced a consultation to change the UK clinical trial...more

Latham & Watkins LLP

European Healthcare & Life Sciences Market Update - H1 2022

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Welcome to the first edition of our European Healthcare & Life Sciences Market Update, a new report summarising key emerging trends, opportunities, and challenges facing the market in 2022. During the last 12 months, the...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - February 2021: Regulatory Updates

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The National Institute for Health and Care Excellence public consultation - The National Institute for Health and Care Excellence (“NICE”) has commenced a public consultation on its technology evaluation process when...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - February 2021: Harnessing Big Data – Draft EU Data Governance Regulation Aims to...

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Key Takeaways - A new draft EU Regulation aims to encourage the sharing and re-use of data and foster a data-driven economy that shares the benefits of Big Data whilst respecting individuals’ rights in personal data and...more

Morgan Lewis

Telehealth in the United Kingdom: Considerations for Providers

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With telehealth surging around the globe due to the COVID-19 pandemic, the UK National Health Services has released guidance that provides a set of good practice principles for third-party partners to follow....more

Hogan Lovells

Coronavirus: The Hill and the Headlines, January 2021 # 5

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In Washington: The White House Coronavirus Task Force is warning that there may be a new fast-spreading U.S.A. variant of the coronavirus. "This fall/winter surge has been at nearly twice the rate of rise of cases as the...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter- December 2020: Regulatory Updates

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Medicines and Medical Devices Bill (MMDB) – The MMDB is intended to act as the primary UK legislation specifying powers that would enable the regulatory regimes for human medicines, clinical trials, veterinary medicines and...more

Dechert LLP

UK Life Sciences and Healthcare Newsletter - December 2020: The UK National Security and Investment Bill

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The UK has announced a bill proposing a new system to screen transactions for national security risk, separate from the system of merger review operated by the Competition and Markets Authority. The National Security and...more

Hogan Lovells

UK post-Brexit regulation of medicines from 1 January 2021

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The UK Medicines and Healthcare products Regulatory Agency ("MHRA") has published a raft of guidance on how various aspects of the UK regulatory regime for medicines will operate in England, Wales and Scotland (together Great...more

Hogan Lovells

UK regulation of medical devices from 1 January 2021

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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

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

Hogan Lovells

[Event] Privacy and Cybersecurity KnowledgeShare – September 19th, London, UK

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Join us on Thursday 19 September for the Hogan Lovells Privacy and Cybersecurity KnowledgeShare in London. We will share our latest thinking on the key privacy and cybersecurity issues faced by those with data protection...more

Hogan Lovells

New UK MHRA No Deal Guidance

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With the possibility of the UK leaving the EU on 29 March 2019 (a "no deal" Brexit) still on the table, life sciences companies are continuing their "no deal" preparations....more

Hogan Lovells

Brexit snapshot: Medicines

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Do you have a centralised EU marketing authorisation holder, orphan designation holder, manufacturing activities including import, batch control or batch release sites, a Qualified Person for Pharmacovigilance (QPPV),...more

Hogan Lovells

Post-registration changes in case of no-deal Brexit

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On 25 February 2019[1], the President of the Polish Office for the Registration of Medicinal Products, Medical Devices, and Biocidal Products issued a communique concerning the necessary post-registration changes in the event...more

Hogan Lovells

Updated UK “no deal” Brexit guidance on medicines, medical devices and clinical trials

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued updated guidance on how the UK would regulate medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019...more

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