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Impact of the new Biotech Act on Clinical Trials in the EU
A European Perspective #1 | EU Biotech Act: Faster Clinical Trial Approvals Ahead | The European Commission’s proposed Biotech Act aims to streamline clinical trial procedures, shorten approval timelines, and harmonise data protection rules across the EU. If adopted, the reform could significantly accelerate multinational clinical research in the EU.
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Promotional activities for medical devices may qualify as agency even without direct negotiation power
A European Perspective #1 | FRANCE | The French Supreme Court confirms a broad interpretation of commercial agent status. A key ruling increasing requalification risks and potential termination indemnity exposure for manufacturers and distributors.
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Ban on “social egg freezing” declared unconstitutional
A European Perspective #1 | AUSTRIA | The Austrian Constitutional Court holds that preventive egg retrieval without medical indication falls within the protection of Article 8 ECHR. A blanket prohibition is disproportionate; the legislature must introduce a new regulatory framework by 31 March 2027.
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Advising on Infinitopes' expanded seed financing to US$35 million
Advising Nuclera on its extended Series C funding to US$87 million
Biotechnologie als Sicherheitsfrage: Warum Dual-Use-Kontrolle und lernende Regulierung über nationale Zukunftsfähigkeit entscheiden
Guidance to manufacturers withdrawing a medical device from the EU market
Medical product availability and healthcare safety are becoming increasingly important talking points. This is also reflected in the EU regulations on medical devices. Although the provisions may seem straightforward their vagueness may give rise to significant doubts as to which situations they will apply to in practice.
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EU and medicines supply issues (part one): Current measures
Marketing Authorisation Holders (MAHs) in the EU are legally required to report medicine supply shortages to the European Medicines Agency and national authorities. This article explores the central role of Marketing Authorisation Holders (MAHs) in identifying and managing medicine supply shortages in the EU as well as the role of EMA committees and working groups in coordinating responses and maintaining the Critical Medicines List to safeguard public health.
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EU and medicines supply issues (part two): Proposals for future measures
In part two of our article on EU and medicine supply issues we explore the key proposals outlined in pharmaceutical reform and their impact on marketing authorisation holders across the region.
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