Optimizing Standardization Systems and Standardizing Clinical Practice:Interpretation of Quality Standards for Medical 68 Ge/68 Ga Generators and 68 Ga Radiopharmaceuticals and Quality Standards for Medical 177 Lu and Its Radiopharmaceuticals
10.12290/xhyxzz.2025-0505
- VernacularTitle:优化标准体系,规范临床实践:《医用锗[68Ge]/镓[68Ga]发生器及镓[68Ga]放射性药物质量标准》和《医用镥[177Lu]及其放射性药物的质量标准》解读
- Author:
Yuxin LAI
1
;
Yumeng PENG
1
;
Guochang WANG
1
Author Information
1. 福建医科大学附属第一医院核医学科,福州 350005;福建医科大学附属第一医院滨海院区国家区域医疗中心核医学科,福州 350212
- Publication Type:Journal Article
- Keywords:
Gallium-68;
Lutetium-177;
radiopharmaceuticals;
group standard
- From:
Medical Journal of Peking Union Medical College Hospital
2025;16(4):867-873
- CountryChina
- Language:Chinese
-
Abstract:
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(68 Ge/68 Ga)Generators and Gallium-68 Radiopharmaceuticals(T/CI 046-2021)and Quality Standards for Medical Lutetium-177(177 Lu)and Its Radiopharmaceuticals(T/CI 047-2021).These standards introduce 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 compre-hensive 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 imple-mentation(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.
