News & Analysis as of

New Legislation Life Sciences European Union

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

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

Jones Day

Revolutionizing EU Design Protection: Key Changes Under the New Designs and Models Regulation

Jones Day on

May 1, 2025, marked the entry into force of most provisions of Phase I of the new Regulation (EU) 2024/2822, which forms part of the "Designs and Models Package" adopted within the European Union. This text, in addition to...more

Morgan Lewis - As Prescribed

New Measures to Encourage Clinical Trials in the United Kingdom

While the US Food and Drug Administration has been experiencing recent reorganization and cuts in personnel, the United Kingdom has its own upcoming policy changes making it easier and faster to initiate and maintain UK...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

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

American Conference Institute (ACI)

[Event] 21st Annual Life Sciences IP Summit - September 27th - 28th, Munich, Germany

Hosted by C5 Group, the 21st Annual Life Sciences IP Summit returns for another exciting year with curated programming with speakers from the pharma, biotech and medical device industries that will provide practical insights...more

A&O Shearman

EU legislative proposals to impose additional obligations on medical device companies

A&O Shearman on

Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more

Hogan Lovells

Poland: Implementation of the EU rules on falsified medicines

Hogan Lovells on

The new law implementing the EU rules on falsified medicines which has been applicable since February 2019 (Commission Delegated Regulation (EU) 2016/161 of 2 October 2015 supplementing Directive 2001/83/EC of the European...more

Latham & Watkins LLP

MHRA Releases No-Deal Brexit Guidance for Life Sciences Companies

Latham & Watkins LLP on

The guidance provides helpful clarity on key regulatory changes impacting life sciences companies in the event of a no-deal Brexit. The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published a...more

Hogan Lovells

New Belgian legislation on the distribution of medical devices

Hogan Lovells on

Today, the Belgian Minister of Health published the new Royal Decree of 19 December 2018 on the liberalisation of the distribution circuit for medical devices....more

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