The clinical translation process in Europe

This chapter describes the process of bringing radiopharmaceuticals from preclinical investigations to first-in-man studies. This translational trajectory—often called moving “from bench to bedside” includes several steps that require attention to specific regulations. As these regulations differ throughout the world, we will describe the current situation in Europe. This chapter will focus on the pertinent legislation currently in force in the European Union (EU) and on legally binding guidelines and document approved by EU regulatory agencies i.e. the European Medicines Agency (EMA) and the European Pharmacopoeia (Ph. Eur.) as well as scientific associations such as the European Association of Nuclear Medicine (EANM) and international bodies such as the International Atomic and Energy Agency (IAEA). Finally, the chapter explores expected future trends, including the growing role of theranostics, increasing industrial involvement, evolving regulatory strategies, and the need for enhanced training and education to support sustained innovation in the field.