New Guidance Concerning Radiopharmaceuticals Supply Chain
The European Medicines Agency and the Heads of Medicines Agencies (HMA) have published Recommendations of the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) to address vulnerabilities in the supply chain of radiopharmaceuticals. The Recommendations concern occasional shortages of radiopharmaceuticals that have arisen throughout the EU as a result of disparity between manufacturing capacity and demand. Shortages are often due to dependency on third countries for the enrichment of stable isotopes and key source materials as well as limited manufacturing capacity at aging research reactors in the EU. The Recommendations advise EU Member States to establish policy measures to support security and continuity of supply of medical radioisotopes in the EU/EEA for the manufacturing of radiopharmaceuticals, including through prioritization of domestic capabilities to reduce dependency on third country sources and to address the limited manufacturing capacity in the EU. They also underline the need for the European Commission to increase domestic capabilities in the EU, and improve infrastructure and production facilities, such as nuclear reactors.