News & Analysis as of

Regulatory Agenda European Union Life Sciences

Bergeson & Campbell, P.C.

EC Begins Public Consultation on Biotech Act

The European Commission (EC) began a public consultation on August 4, 2025, on the European Biotech Act in the form of an online questionnaire. According to the EC, the aim is to gather evidence and views from stakeholders...more

Skadden, Arps, Slate, Meagher & Flom LLP

The European Health Data Space – What EU Health Care Providers and Data Holders Need To Know

- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

White & Case LLP on

Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - 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 & Schulte

Private Markets Update | Summer 2024

McDermott Will & Schulte 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

American Conference Institute (ACI)

U.S. Implications of the EU AI Act

The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more

McDermott Will & Schulte

International News: Spotlight on Innovation - Issue 60

Innovation fuels business growth and ushers in success, yet it brings its own set of challenges. In our latest issue, we explore innovative products and processes including: - The EU’s new Unified Patent Court...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 & Schulte

International News: Spotlight on Foreign Investment

McDermott Will & Schulte on

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 & Schulte

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

McDermott Will & Schulte on

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

A&O Shearman

Updated transparency rules for EU clinical trials - the end of the deferral mechanism

A&O Shearman on

Following a public consultation period this summer, the European Medicines Agency (EMA) published revised transparency rules (s. here) for the EU Clinical Trials Information System (CTIS) on 6 October 2023. The CTIS serves as...more

A&O Shearman

Commission proposal for a new European legal framework for GMOs

A&O Shearman on

In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more

McDermott Will & Schulte

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 & Schulte

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

Hogan Lovells

Actualités Législatives et Réglementaires – Janvier 2023

Hogan Lovells on

Le bureau Parisien de Hogan Lovells a le plaisir de vous adresser sa lettre d'information mensuelle qui vous présente les Actualités législatives et réglementaires du mois de janvier 2023. Ces Actualités législatives et...more

Hogan Lovells

Actualités Législatives et Réglementaires – Novembre 2022

Hogan Lovells on

Le bureau Parisien de Hogan Lovells a le plaisir de vous adresser sa lettre d'information mensuelle qui vous présente les Actualités législatives et réglementaires du mois de novembre 2022. Ces Actualités législatives et...more

Butler Snow LLP

Go-Live of the EU’s Clinical Trial Information System Completes Implementation of the EU’s 2014 Clinical Trial Regulation:...

Butler Snow LLP on

From 2004 to 2014, clinical trials in the EU and countries in the European Economic Area (collectively known as EU/EEA Countries) were subject to the EU Clinical Trial Directive 2001/20/EC (CTD) which set rules for conducting...more

Hogan Lovells

The new Clinical Trials Regulation – what you need to know now - Episode 4: Protection of vulnerable groups.

Hogan Lovells on

With this series we provide insights on what you need to know now about the new EU Clinical Trials Regulation (“CT Regulation”). Episode : Protection of vulnerable groups This part of the series is about the protection of the...more

McDermott Will & Schulte

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

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 & Schulte

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), 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

Hogan Lovells

COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

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In Tuesday's Report: European Commission proposes far-reaching pharmaceutical strategic plan, Biden names health care nominees, and warnings over Christmas COVID-19 spread....more

Hogan Lovells

EMA publishes list of COVID-19 treatments that have been the subject of the Agency’s guidance

Hogan Lovells on

On 30 October 2020, the European Medicines Agency (“EMA”) published a list containing all COVID-19 treatments and vaccines that have so far been the subject of scientific advice or informal guidance from EMA’s pandemic Task...more

Hogan Lovells

New medical device regulation in Spain opened for public consultation

Hogan Lovells on

Spain’s Ministry of Health initiated proceedings for approval of the new regulation on medical devices with a call for a prior public consultation to receive contributions from interested parties....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

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