Radiopharmacy: regulations and legislations in relation to human applications

Radiopharmaceuticals (RPs) have attracted tremendous interest as molecular imaging tracers in diagnostic applications and as biomarkers in drug development, in particular using Positron Emission Tomography (PET). This article summarizes important legal documents and guidelines in relation to human application of PET-RPs that pose a major challenge in implementing the full potential of this technology, thereby differentiating the US from the European situation. Regulations are reviewed with respect to licensing, conducting clinical trials and RP production – including Good Manufacturing Practice (GMP) for radioactive compounds. Professional requirements, including education, are discussed, with an outlook on future developments.