Regulatory challenges and key considerations in the development of radiopharmaceuticals
By Dr Asha Kattige, Dr James Parsley, Dr Hannah Lewis, Dr Maria Beatrice Panico, Dr Lewis Penny and Savannah Orth2026-01-14T09:41:00
Abstract
Radiopharmaceuticals are a distinct class of radioactive medicinal products used for both diagnostic imaging and targeted therapy. The choice of isotope and type of radiation emitted dictates whether a radiopharmaceutical functions as a radiodiagnostic or radiotherapeutic.
Their use in humans carries inherent risks that differ from conventional pharmaceuticals due to the radioactive nature of the compounds. Consequently, successful advancement of these products hinges on a highly specialised strategy, tailored to address the distinctive scientific, regulatory and logistical challenges inherent to radiopharmaceuticals.