Intricacies in the approval of radiopharmaceuticals - regulatory perspectives and the way forward

Abstract

Extensive research by the global scientific fraternity has led to the production of many radiopharmaceuticals of immense clinical importance. However, this increasing availability has not been matched by adequate regulatory action to back up the legal foundation for their commercial use. It is imperative for a radiopharmaceutical to have a seal of regulatory authority approval to qualify for human use. The present article highlights various regulatory requirements for approval of radiopharmaceuticals in USA, Europe, and particularly India, which does not have guidelines for their approval, and intensifies the concern for a harmonized regulatory platform of global acceptance.