News & Analysis as of

Regulatory Reform Regulatory Requirements European Union

Hogan Lovells

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

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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

A&O Shearman

ESMA feedback statement on the private securitisation reporting regime

A&O Shearman on

ESMA has published its feedback statement on the outcome of its consultation on the private securitisation reporting regime. ESMA had previously consulted on introducing changes to the disclosure regime including in relation...more

Jones Day

Reform of the EU Securitisation Framework—Part 3: "Resilient Securitisations"

Jones Day on

On 17 June 2025, the European Commission (the "Commission") published its proposed measures to revive the securitisation framework in the European Union ("EU"), with a view to making it simpler and more fit for purpose. This...more

Hogan Lovells

Pharmacy compounding under the EU pharma law package

Hogan Lovells on

Pharmacy compounding is one of the topics in the EU Pharma Law Package that has perhaps received less attention compared to topics such as regulatory exclusivity rights, shortages, and sustainability. The EU Pharma Law...more

Morrison & Foerster LLP

European Digital Compliance: Key Digital Regulation & Compliance Developments - August 2025

To help organizations stay on top of the main developments in European digital compliance, Morrison Foerster’s European Digital Regulatory Compliance team reports on some of the main topical digital regulatory and compliance...more

Paul Hastings LLP

UK Public Offers and Admissions to Trading Regime

Paul Hastings LLP on

The principal regulations governing offers of securities to the public and admissions of securities to trading on regulated markets in the United Kingdom, including the requirements for a prospectus, are contained in the UK...more

Ropes & Gray LLP

SFDR Review Potentially Delayed to Q1 2026

Ropes & Gray LLP on

Whilst not unexpected, the long-awaited review of the EU Sustainable Finance Disclosure Regulation (SFDR), originally scheduled for Q4 2025, is now likely to be delayed to Q1 2026. This follows the public and targeted...more

Jones Day

Stablecoins: Revolutionizing Global Finance?

Jones Day on

Following the recent focus on two major regulatory frameworks—the Guiding and Establishing National Innovation for U.S. Stablecoins Act (known as the GENIUS Act) in the United States, and Regulation (EU) 2023/1114 of the...more

Ropes & Gray LLP

Seeing the Forest for the Trees: Further Changes to the EU Deforestation Regulation are Likely

Ropes & Gray LLP on

The EU Deforestation Regulation (EUDR) covers cattle, cocoa, coffee, oil palm, rubber, soy(a) and wood, as well as many derived products. The Regulation is currently scheduled to apply to operators and traders beginning at...more

Eversheds Sutherland (US) LLP

Global Supply Chain Horizons - July 2025

Welcome to the latest edition of our quarterly global supply chain horizons providing you with a update on the key developments from around the world. Cross-Border - China and the US trade deal - On June 27, the PRC...more

Wilson Sonsini Goodrich & Rosati

EU Releases Final Code of Practice for General-Purpose AI Models

On July 10, 2025, the European Commission (EC) published the final version of the General-Purpose AI Code of Practice (Code). This voluntary instrument provides guidance on how providers of general-purpose AI models (GPAI),...more

Akin Gump Strauss Hauer & Feld LLP

EU Moves to Simplify Taxonomy Disclosures Without Undermining Green Goals

On July 4, 2025, the European Commission (EC) adopted a “Delegated Act Amending the Taxonomy Disclosures, Climate and Environmental Delegated Acts,” marking a significant shift in how companies will interact with the European...more

White & Case LLP

EU unveils methodology to calculate emissions savings in low-carbon fuels

White & Case LLP on

The European Commission is ramping up support for low-carbon "blue" hydrogen, increasingly positioning it alongside renewable "green" hydrogen as a key pillar of the EU's future energy mix. On July 8, 2025, the European...more

McDermott Will & Schulte

Proposals For Relaxation of EU Securitization Framework

Vlad Maly and Michal Chajdukowski present the key takeaways from a package of amendments to the existing EU securitization framework, published by the European Commission on June 17, 2025. The proposals aim at...more

Barnea Jaffa Lande & Co.

Israel’s Import Reform: “What’s Good for Europe Is Good for Israel”

The “What’s Good for Europe Is Good for Israel” reform came into effect at the beginning of 2025, with considerable. This reform allows importers to import diverse products to Israel in a new standardization track, based on...more

A&O Shearman

EBA publishes technical advice to EC on fees to validate pro forma models under EMIR

A&O Shearman on

The European Banking Authority (EBA) has published technical advice to the European Commission, alongside a press release, on a possible Delegated Act concerning fees for the validation of pro forma models under the European...more

White & Case LLP

European Commission tables proposals to cut red tape for defence industry

White & Case LLP on

On 17 June 2025, the European Commission issued the Defence Readiness Omnibus, through which it proposes to amend key pieces of EU legislation to remove regulatory obstacles for the EU defence market. The initiative is part...more

Jones Day

The EU's Deforestation Regulation: Will There Be Further Changes?

Jones Day on

The EU's Deforestation Regulation (EUDR), designed to ensure that no products that contribute to deforestation are sold in, or exported from, the EU, continues to be criticized by EU Member States and major market players....more

Skadden, Arps, Slate, Meagher & Flom LLP

Something Is Better Than Nothing: UK and EU GDPR Reform Finally Arrives

In recent weeks, the EU and UK have both introduced changes to their respective versions of Europe’s landmark privacy legislation, the General Data Protection Regulation (GDPR). These reforms mark the first substantial...more

A&O Shearman

ESAs launch joint consultation on draft guidelines for ESG stress testing

A&O Shearman on

The European Supervisory Authorities (the European Banking Authority, European Insurance and Occupational Pensions Authority and the European Securities and Markets Authority) have launched a joint consultation on their joint...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

Skadden, Arps, Slate, Meagher & Flom LLP

MiCA Update – Six Months in Application

The Markets in Crypto-Assets Regulation (MiCA) has now been in full effect for six months. This landmark piece of legislation, which is designed to create a harmonized regulatory framework for cryptoassets across the EU,...more

DLA Piper

Ireland: NIS2 Revamps Ireland’s Cybersecurity Landscape: Old Regulators, New Powers

DLA Piper on

The NIS2 Directive has significantly reshaped the cybersecurity landscape across the EU. Since the implementation deadline in October 2024, EU Member States have been working to incorporate new standards into their national...more

Jones Day

ESRS Simplification: Updated Timeline and Expectations

Jones Day on

The European Commission has extended the deadline for the European Financial Reporting Advisory Group (EFRAG) to submit its technical advice on simplifying the European Sustainability Reporting Standards (ESRS) under the...more

A&O Shearman

ESMA publishes technical advice on eligible assets for UCITS

A&O Shearman on

The European Securities and Markets Authority (ESMA) has published its final technical advice to the European Commission (EC) on the review of the UCITS Eligible Assets Directive (EAD) accompanied by a press release. The EAD...more

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