Recent years have seen the establishment of several radionuclides as medicinal
products in particular in the setting of theranostics and PET. [177Lu]Lutetium Chloride or
[64Cu]Copper Chloride have received marketing authorization as radionuclide precursor,
[68Ga]Gallium Chloride has received regulatory approval in the form of different
68Ge/68Ga generators. This is a formal requirement by the EU directive 2001/83,
even though for some of these radionuclide precursors no licensed kit is available
that can be combined to obtain a final radiopharmaceuticals, as it is the case for
Technetium-99m. In view of several highly promising, especially metallic radionuclides
for theranostic applications in a wider sense, the strict regulatory environment poses the
risk of slowing down development, in particular for radionuclide producers that want
to provide innovative radionuclides for clinical research purposes, which is the basis
for their further establishment. In this paper we address the regulatory framework for
novel radionuclides within the EU, the current challenges in particular related to clinical
translation and potential options to support translational development within Europe
and worldwide
