Author: Caridad Borras 👨🔬
Affiliation: Radiological Physics and Health Services 🌍
Purpose: The production, use, and disposal of radiopharmaceuticals must comply with regulations for drugs (medicines) and radiation. The relevant roles and requirements for medical physicists to be involved in these legislative processes will be explored.
Methods: The essential features of agencies responsible for regulating radiopharmaceuticals, including medical physics requirements, will be described. While the focus will be on the United States (US), European Union (EU), and Australian standards will be compared as appropriate.
Results: In the US, the Food and Drug Administration (FDA) is responsible for approving radiopharmaceuticals for human use and defines as “radiopharmaceutical” any human-use radionuclide, such as I-131. The Nuclear Regulatory Commission (NRC) and the State Radiation Control Authorities are responsible, inter alia, for the production, transportation, use, and disposal of radioactive materials, including radiopharmaceuticals. In Australia, radiopharmaceuticals are regulated by the Therapeutic Goods Act (TGA) and the Australian Radiation Protection and Nuclear Safety Agency. In the European Union, the European Medicines Regulatory Network, through the European Commission (EC), regulates medicine agencies of EU countries based on recommendations by the European Medicine Agency. International guidelines on medicine development are provided by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The EC, the TGA, and the FDA are ICH members. For radiation control, most countries adopt/adapt the International Basic Safety Standards for Radiation Protection and Safety, elaborated by several international organizations under the aegis of the IAEA. EU countries' Radiation Control Authorities are to follow EU Council Directives' radiation standards. The significant difference between current EU and US regulations regarding radiotheranostic dosimetry requirements will be presented, and the roles medical physicists can play in making needed changes will be discussed.
Conclusion: Medical physicists should impact the development or update of radiopharmaceutical regulations.