The European Biotech Act & its impact on clinical trials

The European Biotech Act marks a significant new chapter for biopharmaceutical innovation in Europe.

In our recent webinar, we provided a concise overview of the European Commission’s proposal and discussed its expected impact on clinical trials under the Clinical Trials Regulation (CTR).

The session explored key developments such as shorter approval timelines for multinational and ATMP studies, a strengthened role of the reporting Member State, and important simplifications for decentralized, minimal-intervention, and combined drug-device trials. We also highlighted the growing influence of digitalization and AI in clinical research regulation.

For more information, including our synopsis of the proposed amendments to the Clinical Trials Regulation (EU) No. 536/2014 under the European Biotech Act, please contact Irina Rebin by email to request the document.