Key Points
• Radiopharmaceuticals are missing from the Biotech Act : despite being a rapidly evolving treatment class, a key pillar of Europe’s Beating Cancer Plan, and an EU strategic priority for innovation and isotope supply security.
• Two regulatory barriers slow patient access: Clinical trials require both clinical trial authorisation AND separate radiation protection approval (variable requirements/unharmonized timelines across Member States), while outdated radiation rules mandate individual patient dosing instead of evidence-based population dosing used for other medicines.
• Proposed solution 1 – Align timelines: Amendments to Regulation (EU) No536/2014 : to sync radiation protection approvals with clinical trial timelines (following Germany’s “single gate” model already in place since July 2025).
• Proposed solution 2 – Regulate as medicines: Article 58(3) • Amend Directive 2013/59/EURATOM Article 56 to exempt therapeutic radiopharmaceuticals from individual dosing requirements, allowing population-based dosing like other medicines while maintaining radiation safety principles.
• Technical update: Align EU CTR Article 91 references with current Directive 2013/59/EURATOM (replacing outdated 1996-1997 Directives).
Read the full position paper