News & Analysis as of

New Regulations International Harmonization European Union

A&O Shearman

Draft EU Foreign Investment Screening Regulation sets out more comprehensive screening regime

A&O Shearman on

On 24 January 2024, the European Commission (EC) published its proposed reform of foreign investment screening in the EU. The proposal introduces more comprehensive rules for the review of foreign investments and strengthens...more

WilmerHale

The EU Data Act: A new European legal framework with rules for data access, switching cloud providers and interoperability

WilmerHale on

On 22 December 2023, the EU published Regulation (EU) 2023/2854, the Data Act, in the Official Journal of the EU. The Data Act is a new regulation providing harmonised rules on access to data, switching cloud providers and...more

Latham & Watkins LLP

New Regulation on Health Technology Assessment Seeks to Facilitate EU-Level Joint Clinical Assessments From 2025

Latham & Watkins LLP on

The regulation aims to harmonise clinical and scientific aspects of HTA to make innovative health technologies more widely available in the EU. Health technology assessment (HTA) is a multidisciplinary evidence-based...more

Barnea Jaffa Lande & Co.

Crowdfunding Platforms – New Regulation in Europe

The European Parliament recently adopted a new regulation on crowdfunding platform activity. This regulation will apply across the board to all European Union countries. The regulation’s adoption sprang from the desire to...more

Latham & Watkins LLP

Time to Prepare for New EU Medical Device Regime

Latham & Watkins LLP on

Companies should act now to prepare for the full implementation of the MDR and IVDR. On 26 May 2020, Regulation (EU) 2017/745 on medical devices (MDR) will become fully active, reflecting an overhaul of the current...more

McDermott Will & Emery

The New EU Clinical Trials Regulation Aims at Harmonization and Transparency

McDermott Will & Emery on

On June 16, 2014, Reg. (EU) No. 536/2014 on Clinical Trials on Medicinal Products for Human Use (Regulation) has entered into force. Once it becomes applicable, the Regulation will provide a comprehensive legal framework for...more

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