方便患者获得放射性药品的立场文件:考虑适当的制药监管框架
Aruna Korde1, Marianne Patt2, Svetlana V Selivanova3,4
1Division of Physical and Chemical Sciences, Department of Nuclear Sciences and Applications, International Atomic Energy Agency, Vienna, Austria.
EJNMMI radiopharmacy and chemistry
|January 2, 2024
概括
改善放射性药物的监管框架可以提高全球患者的获取. 这涉及解决独特的产品特征,并确保全球一致的质量和可用性.
科学领域:
- 核医学是一种核医学.
- 放射性药物科学 是一种放射性药物科学.
- 监管事务 监管事务
背景情况:
- 核医学已经取得了显著的进步,但患者获得放射性药物的机会在全球范围内仍然不平等.
- 对放射性药物的不平等获取阻碍了不同国家的公平患者护理.
- 提高放射性药品的可用性是缓解获取差异的关键.
研究的目的:
- 概述放射性药品制药监管框架的基本要素.
- 为了促进更广泛的患者获得关键的放射性药物疗法.
- 为应对放射性药品监管和供应方面的挑战.
主要方法:
- 总结放射性药品监管框架的关键考虑因素.
- 分析不同的放射性药物特性,需要定制的法规.
- 审查制造,质量保证和营销许可程序.
主要成果:
- 由于放射性药物的独特性质,需要专门的法规.
- 框架必须解决准备的复杂性,人员,制造和质量保证.
- 市场授权和供应链战略对于可用性至关重要.
结论:
- 专家的共识强调了对放射性药物的具体监管方法的需要.
- 这些发现源自2023年国际原子能机构技术会议.
- 建议旨在改善放射性药物的全球获取和可用性.
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