The SIMPLERAD project was a study under the SAMIRA action plan on the implementation of the Euratom and EU legal bases with respect to the therapeutic uses of radiopharmaceuticals.
The study explored quality and radiation safety issues related to the current use and introduction of novel therapeutic radiopharmaceuticals into clinical practice, the role of medical physics experts, requirements for dosimetry, release of patients from hospital, and management of radioactive waste. Given their chemical, physical and clinical particularities, radiopharmaceuticals are a very special class of drugs that requires specific considerations, but their preparation, handling and use are regulated in two separate legal frameworks. The SIMPLERAD project examined legislation and international regulations and guidelines; conducted a survey and interviews of competent authorities, professional societies and clinicians; and hosted a workshop in order to develop a final report proposing practical guidance and recommendations to advance coherent implementation of the legal requirements with respect to the therapeutic use of radiopharmaceuticals. The document aims to improve the understanding of the links and interdependencies between the European pharmaceutical legislations and Euratom radiation protection requirements and highlight potential barriers to coherent implementation of radiopharmaceutical therapies in clinical practice.
The SIMPLERAD project ran from 2023–2025 and involved experts from EIBIR, EANM and EFOMP. The project’s Advisory Board lent invaluable guidance from such organizations as HERCA, the IAEA, ICRP, Nuclear Medicine Europe and EURAMED.
Read or download the final report from the Publications Office of the EU.