Justification
Radiopharmaceuticals (RPh) and radioisotopes (RI) are uniquely time-sensitive medical products, characterized by radioactive decay that directly impacts their clinical usability. Their safe and effective delivery requires highly specialized packaging, appropriate radiation shielding, strict temperature control, and full compliance with rigorous safety and regulatory standards.
In addition, the regulatory landscape governing the production, transport, and use of these materials varies significantly across countries and regions, adding further complexity. The supply chain operates under a “just-in-time” model, with no possibility for inventory buffering, requiring precise coordination between production facilities, transportation networks, and clinical end-users to ensure timely delivery and optimal patient care.
These challenges are further compounded by logistical constraints, limited transport capacity, and the need to meet stringent quality standards within very short timeframes. Importantly, these barriers differ across countries, reflecting variations in infrastructure, regulatory frameworks, and access to specialized transport systems.
Given the critical importance of ensuring reliable access to radiopharmaceuticals for both diagnostic and therapeutic procedures, it is essential to better understand these challenges from the perspective of services and industry stakeholders.
We kindly request your collaboration in completing the questionnaire below regarding delays/denials of shipment of radiopharmaceuticals and radioisotopes in your country. Your input will be invaluable in identifying key barriers, informing policy, and supporting strategies to strengthen the production and distribution of radiopharmaceuticals and radioisotopes globally.
