Optimizing Standardization Systems and Standardizing Clinical Practice: Interpretation of Quality Standards for Medical ⁶⁸Ge/⁶⁸Ga Generators and ⁶⁸Ga Radiopharmaceuticals and Quality Standards for Medical ¹⁷⁷Lu and Its Radiopharmaceuticals

On January 1, 2022, the China International Association for the Promotion of Science and Technology (CIAPST) officially implemented two pivotal standards: Quality Standards for Medical Germanium-68/Gallium-68 (⁶⁸Ge/⁶⁸Ga) Generators and Gallium-68 Radiopharmaceuticals (T/CI 046-2021) and Quality Standards for Medical Lutetium-177 (¹⁷⁷Lu) and Its Radiopharmaceuticals(T/CI 047-2021). These standardsintroduce innovative requirements for quality control and clinical application of radiopharmaceuticals, marking a significant advancement in China's regulatory framework for nuclear medicine.This article provides a comprehensive analysis of the technical rationale, QC protocols, and clinical implications outlined in the standards. Against the backdrop of China's evolving nuclear medicine landscape, we further identify challenges in implementation (e.g., production consistency, regulatory compliance) and propose actionable strategies to optimize radiopharmaceutical quality management systems. Our perspective aims to support the standardization and global integration of China's radiopharmaceutical industry.