Tackling vulnerabilities in the supply chain of radiopharmaceuticals in the EU

EMA and the Heads of Medicines Agencies (HMA), through the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), have issued recommendations to address vulnerabilities in the supply chain of radiopharmaceuticals. These types of medicines contain radioactive forms of chemical elements called radioisotopes and are used to diagnose or treat medical conditions such as cancer. Their use is steadily increasing, while manufacturing capacity in Europe is limited. This has led to occasional shortages in different Member States. Production of radiopharmaceuticals is reliant on stable isotopes and other materials that are sourced mainly from third countries. In addition, the supply chain of these medicines, including how to transport them safely, is complex. The MSSG recommendations are directed to European and national authorities, as well as to industry with the aim to align efforts to address these issues. The recommendations to the European Commission emphasise the need to increase the European Union’s domestic capabilities through initiatives such as the European Observatory on the Supply of Medical Radioisotopes, co-chaired by the Euratom Supply Agency (ESA) and Nuclear Medicine Europe (NMEU), the Strategic Agenda for Medical Applications of Ionising Radiation (SAMIRA) and the European Radioisotope Valley Initiative (ERVI). They highlight improving aging infrastructure and enhancing production facilities, such as nuclear reactors. They also consider...