First part of the BioTech Act Published (Dec. 2025)

EANM responds to the publication of the first part of the EU BioTech Act

EANM takes note of the publication today of the first part of the EU BioTech Act, which sets out measures to strengthen Europe’s biotechnology framework, with a particular focus on health innovation and regulatory efficiency.

The Act introduces changes intended to speed up clinical trial approvals and encourage early dialogue between developers and regulators. For nuclear medicine, where innovation often relies on complex, multidisciplinary development pathways and time-sensitive clinical studies, more predictable and streamlined procedures could support faster translation of new radiopharmaceuticals from research into clinical practice.

The proposal also outlines new incentives and investment tools to support advanced health technologies, alongside regulatory sandboxes that allow controlled testing of innovative approaches. These mechanisms may offer opportunities to explore novel production methods, diagnostics and therapeutic applications relevant to nuclear medicine, while maintaining high safety standards.

EANM welcomes efforts to modernise Europe’s regulatory environment and will follow the implementation of the Biotech Act closely. As discussions continue and future legislative steps are prepared, EANM looks forward to engaging with EU institutions to ensure that the specific characteristics of nuclear medicine and radiopharmaceuticals are appropriately reflected, with patient access and clinical impact at the centre.

Published online: December 17, 2025.