The growing armamentarium of potential radioisotopes and increased demand for radiopharmaceuticals (RPs) have catapulted their biomedical applications on a trajectory of higher growth in the modern healthcare establishment. Nuclear medicine technology is now regarded as an essential tool for diagnosis, palliation, therapy, and theranostic applications. The associated radiation safety issues need to be emphasized in the form of adequate regulatory action to warrant their safe and effective use. The RPs attracts considerable attention from both pharmaceutical and nuclear regulators due to their constituent pharmaceutical and radioactive components. So, a critical examination of applications of RPs, the latest advances in their development, and the existing regulatory guidelines for RPs have been carried out. This review presents a brief overview of RPs and recent studies on their diagnostic, therapeutic, and theranostic applications. Comprehensive comparative information on regulatory perspectives of RPs in major pharmaceutical jurisdictions such as the United States (US), the European Union (EU), and India reveals ambiguities and heterogeneity. The present studies discuss the importance of RPs in the current healthcare domain, their recent applications, and strive to intensify the concern for an ambient and harmonized regulatory setup.
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