News & Analysis as of

Regulatory Standards Supply Chain European Union

Akin Gump Strauss Hauer & Feld LLP

EU Ratifies Pioneering Artificial Intelligence Legislation

On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more

NAVEX

GRC Latest News – AI Benefits Your Compliance Program

NAVEX on

Artificial intelligence (AI) is transformative technology that has captured industries worldwide and is here to stay. Defined as a system designed to operate with a certain level of autonomy, AI uses machine learning and...more

Latham & Watkins LLP

European Commission Releases Communication on the Green Deal Industrial Plan

Latham & Watkins LLP on

The Plan aims to “simplify, accelerate and align incentives to preserve the competitiveness and attractiveness of the EU as an investment location for the net-zero industry”. On 1 February 2023, the European Commission...more

Dechert LLP

Upcoming Regulatory Initiatives Impacting Private Fund Managers - September 2022

Dechert LLP on

This latest edition of the regulatory initiatives paper sets out at a high level the core regulatory issues that are likely to impact private fund managers in the coming months, including an overview of the key actions needed...more

Hogan Lovells

Key legal concerns for advanced therapy medicinal product (ATMP) sponsors in Europe

Hogan Lovells on

In recent years we have seen more and more gene and cell therapies coming successfully to market – but many more such candidates have not made it to market, or been unable to obtain sufficient reimbursement. Gene and cell...more

Hogan Lovells

AI & Algorithms (Part 2): The EU releases its new regulation on artificial intelligence

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On 14 April 2021, the EU Commission’s long-awaited draft proposals for the regulation of artificial intelligence (AI) were leaked. The proposals, which are due to be formally announced on 21 April, set out a bold and...more

Akin Gump Strauss Hauer & Feld LLP

EU-UK Trade and Cooperation Agreement: Initial Impact on Trade Topics

The U.K. and the EU conclude the EU-UK Trade and Cooperation Agreement, which entered into force on December 31, 2020. The Agreement provides guidance on origin rules that must be met for products to benefit from duty-free...more

Hogan Lovells

The European Commission proposes a new Pharmaceutical Strategy for the EU

Hogan Lovells on

On 25 November 2020, the European Commission published a proposal for a new Pharmaceutical Strategy for Europe (“the Strategy”). The Strategy is built around four main objectives, each with an assigned work strand....more

Hogan Lovells

EMA publishes guidance providing regulatory adaptations for MAHs in the context of COVID-19

Hogan Lovells on

On 10 April 2020, the European Commission, the EMA and the European medicines regulatory network published a notice providing guidance to stakeholders regarding regulatory expectations for medicinal products for human use...more

Hogan Lovells

Supplying medical devices without CE mark in the Netherlands during COVID-19

Hogan Lovells on

In response to the COVID-19 outbreak, the Dutch Healthcare and Youth Inspectorate grants manufacturers and suppliers of medical devices the temporary opportunity to supply medical devices without a CE mark or without having...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l August 2019

LEGISLATION, REGULATIONS & STANDARDS - Bipartisan Bill Introduced to Standardize Food Date Labels - U.S. Reps. Chellie Pingree (D-Maine) and Dan Newhouse (R-Wash.) have introduced the Food Date Labeling Act, which aims...more

Hogan Lovells

Brexit snapshot: Automotive & Mobility

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Do you work in the automotive & mobility industry in the UK? Do you manufacture or sell vehicles, or parts of vehicles, in the UK? Are your manufacturing activities, suppliers, customers or contracting parties located in the...more

Hogan Lovells

European Commission publishes factsheet on the (in vitro) medical devices procurement ecosystem

Hogan Lovells on

The European Commission has published a factsheet addressed to organisers of public tenders involving medical devices. The goal of the factsheet is to provide hospitals, clinics, ministries and competent authorities...more

Hogan Lovells

HMA-EMA’s work programme on availability of authorised medicines for human and veterinary use includes measures for Brexit

Hogan Lovells on

On 23 August 2018, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA), the network of the National Competent Authorities in the European Economic Area (EEA), published the work programme of their...more

Hogan Lovells

What’s trending: The factors that can trigger supply chain disruption and litigation in the life sciences industry

Hogan Lovells on

Change is coming to the life sciences industry. Price pressure, new market entrants, the emergence of personalized medicine, and even climate change are adding complexity to traditional manufacturing processes and supply...more

Hogan Lovells

European Commission Publishes Guidance on Brexit and UK Food Exports

Hogan Lovells on

On 1 February 2018, the European Commission issued a notice on the impact of Brexit for food products originating from the UK. The Commission confirmed that, in the absence of a transitional agreement, the UK will become a...more

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