Regulatory Aspects of Cold Kit-Based Radiopharmaceuticals in the EU

The cold kit approach is a fast and easy method for labeling tracers with radiometals used in Nuclear Medicine for 99mTc-radiopharmaceuticals since decades. The clinical success of some radiopharmaceutical labelled with Ga-68, a generator-based PET isotope, followed by the availability of registered generators and the development of new chelators, boosted the interest in development of cold kit-based ⁶⁸Ga- radiopharmaceuticals as for ^99mTc. The aluminium fluoride-18 (Al[¹⁸F]F) radiolabelling is an interesting “one-pot” method which involves the formation of ¹⁸F-metal complex trapped by a suitable chelator. This approach simplifies the ¹⁸F-labeling methodology along with the possibility to obtain a kit-based radiofluorination. In this session, the recent developments in kit-based labeling of ⁶⁸Ga- radiopharmaceuticals and in Al[¹⁸F]F labeling will be discussed. Finally, since the regulatory aspect is an important issue for using cold kit preparations in clinical practice, an overview of the different regulations in European countries will be showed and discussed.