Exploration of the Traceability System in Radiopharmaceuticals

Abstract

In recent years, the rapid iteration of innovative technology products in the biomedical industry has given rise to the emerging field of radiopharmaceuticals, which brings with it a series of complex and distinct challenges. Although the popularization of drug regulatory science and technology has achieved the standardization of drug regulatory governance system and effectively covered drug regulatory undertakings, there remains a lack of a scientific, effective and systematic regulatory system for the production, utilization and health effect evaluation of radiopharmaceuticals. To address the prominent issues of radiopharmaceutical supervision in China, it is crucial to focus on market conditions, clinical needs, drug technical review, and other pertinent factors as key areas of concern. By conducting systematic research from the perspective of whole-process cycle management, efforts can be made to explore and summarize the traceability mechanism system for the production process of radiopharmaceuticals, and to clarify the key direction, basic framework and management path of supervision. This will facilitate the establishment of a supervision system that is in line with the characteristics of radiopharmaceuticals and adaptable to their development, thereby promoting the industrial advancement of the industry. Moreover, it will guide the domestic radiopharmaceutical field towards achieving scientific and high-quality development, effectively addressing the unmet clinical needs of patients.

Keywords

• radiopharmaceuticals
• regulatory science
• regulatory governance system
• health effect evaluation