The 2026 Pharma Package: A New Regulatory Framework for Medicinal Products in the EU
15 avril 2026
Actualités et publications récentes
International Life Sciences Newsletter - Life Sciences Legal Lens Vol 1
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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.
15 avril 2026
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4 de 9 Publications
International Life Sciences Newsletter - Life Sciences Legal Lens Vol 1
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No claim for damages as a result of participation in clinical drug trials
A European Perspective #1 | GERMANY | The Frankfurt am Main Regional Court confirms: No reduction in the burden of proof (presumption of causality) pursuant to Section 84 (2) of the German Medicines Act (AMG) for IMP (not even by analogy) and no liability on the part of the sponsor in the event of (insufficient) risk information provided by the investigating physician.
1 avril 2026
7 de 9 Publications
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