推进全球协调:为药品识别实施全球剂型属性
Emelie Ahnfelt1, Olof Lagerlund2, Jenny Klint2
1Uppsala Monitoring Centre, Uppsala, Sweden. emelie.ahnfelt@who-umc.org.
Therapeutic innovation & regulatory science
|August 7, 2025
概括
全球剂型属性已成功应用于九个国家的99%以上的药品,在全球范围内标准化药品. 地点术语的映射改善了药品识别框架 (IDMP) 的属性赋值.
科学领域:
- 制药科学 制药科学
- 监管事务 监管事务
- 数据标准化数据标准化
背景情况:
- 全球制药市场面临着跨地区一致的药品识别和分类方面的挑战.
- 国际标准化组织 (ISO) 制定了药品识别 (IDMP) 标准,以解决这些不一致的问题.
- 标准化对于全球监管协调和数据交换至关重要.
研究的目的:
- 探索引入全球剂量形式属性的可行性,以便在全球范围内对药品进行标准化.
- 定义和应用标准化剂型特征,包括可施用的基本剂型,施用方法,预期部位和释放特征.
- 在IDMP框架内提高药品数据的一致性和准确性.
主要方法:
- 定义了与欧洲药品质量总局 (EDQM) 合作的全球剂量形式属性.
- 将这些属性应用于来自九个国家的药品数据,涵盖六种不同的剂量形式术语.
- 开发了一个映射过程,将局部剂量形式的术语与全球属性联系起来.
- 建立了基于研究结果分配全球剂量形式属性的业务规则.
主要成果:
- 在分析的99%以上的药物中,成功地将全球剂量形式属性分配给了99%以上的药物.
- 映射过程显著提高了属性赋值的效率和准确性.
- 该研究表明,在各种各样的国家术语中,标准化方法的成功应用.
结论:
- 全球剂量形式属性是可行和有效的,用于全球标准化药品信息.
- 将当地术语映射到全球属性是成功实施IDMP标准的关键策略.
- 这项工作为全球一致的药品识别和监管数据管理提供了基础.
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