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

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

  • 摘要: 2022年1月1日, 中国国际科技促进会发布了《医用锗68Ge/镓68Ga发生器及镓68Ga放射性药物质量标准》(T/CI 046-2021)和《医用镥177Lu及其放射性药物的质量标准》(T/CI 047-2021), 对放射性药物的质量控制、临床规范应用等提出了新要求, 标志着我国在放射性药物标准化管理领域取得进一步发展。本文结合核医学发展现状, 对该两项标准的技术背景、质量控制以及临床应用等核心内容进行解读, 同时基于我国核医学发展现状, 指出标准实施面临的挑战及对策, 以促进我国放射性药物质量控制体系的完善与发展。

     

    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 (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.

     

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