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European Commission Regulatory Requirements Transparency

Foley & Lardner LLP

Introducing the EU AI Act

Foley & Lardner LLP on

Understanding the need for regulation to ensure the safe use of AI, the European Union (EU) has introduced the world’s most comprehensive legal guideline, EU AI Act, designed to impose strict requirements on AI systems...more

A&O Shearman

Zooming in on AI #11: EU AI Act – What are the obligations for the limited-risk AI systems

A&O Shearman on

The EU Artificial Intelligence Act (“AI Act”) exemplifies a highly advanced risk-based approach to European regulation. One of its distinguishing features is the detailed classification of various risk levels associated with...more

White & Case LLP

Draft EuGB Regulation and implications for future green ABS

White & Case LLP on

On 10 May 2023, the Council of the European Union (the "Council") submitted a draft for a European Green Bonds Regulation (the "Draft EuGB Regulation") to the European Parliament for review and approval....more

Perkins Coie

Europe Seeks to Tame Artificial Intelligence with the World’s First Comprehensive Regulation

Perkins Coie on

In what could be a harbinger of the future regulation of artificial intelligence (AI) in the United States, the European Commission published its recent proposal for regulation of AI systems. The proposal is part of the...more

Hogan Lovells

European Commission provides clarification regarding the implementation of the Clinical Trials Regulation

Hogan Lovells on

The European Commission has published an updated Questions and Answers document concerning the Clinical Trials Regulation (EU) 536/2014. The document provides clarification regarding the implementation of the rules governing...more

Jones Day

The Proposed SPC Export Manufacturing Waiver: Really a Balanced Approach?

Jones Day on

The Situation: For the pharmaceutical industry, supplementary protection certificates ("SPC") are probably the most valuable IP rights. While the scope of protection of an SPC is determined separately from the scope of...more

Hogan Lovells

European Commission proposes SPC waiver for EU biosimilars or generics manufactured solely for export from the EU

Hogan Lovells on

On 28 May 2018, the European Commission published a draft regulation amending Regulation 469/2009 concerning the supplementary protection certificate for medicinal products....more

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