Abstract: Objective To analyze the challenges facing pharmacovigilance related to radioprotective drugs and propose optimization strategies so as to promote safe and rational clinical use of drugs. Methods Through literature review, radioprotective drugs and the identified representative agents were categorized. Major problems with pharmacovigilance were summarized while corresponding countermeasures were proposed. Results Radioprotective drugs were classified into three major categories: radioprotective agents, radiation mitigators, and radiotherapeutic agents. Five major challenges were identified: inadequate regulatory frameworks, insufficient research on pharmacology and toxicology, the lack of real-world data, difficulties in detecting adverse reactions, and imperfect data collection and sharing mechanisms. Conclusion A multidimensional approach is required to enhance the pharmacovigilance system for radioprotective drugs by strengthening regulatory frameworks, broadening nonclinical and clinical research, establishing real-world data platforms, developing intelligent risk identification tools, and promoting data sharing and international collaboration to ensure medication safety and efficacy.

Key words: Radioprotective Drugs, Radiation, Radiation Mitigators, Radioprotective Agents, Radiotherapeutic Agents, Pharmacovigilance, Adverse Drug Reaction