英国药品批准的国际比较:回顾性分析
Ayomikun Oluwaseun Ogunyemi1, Cyril Onwuelazu Uteh2, Ross Fairbairn2
1National Institute for Health and Care Research Innovation Observatory, Newcastle University, Newcastle upon Tyne, UK ayomikun.ogunyemi@newcastle.ac.uk.
BMJ open
|November 17, 2025
概括
英国的英国.
科学领域:
- 制药监管事务 制药监管事务
- 卫生技术评估 卫生技术评估
- 全球医学可访问性
背景情况:
- 英国药品和医疗保健产品监管局 (MHRA) 正在引入国际认可程序 (IRP).
- 了解IRP之前的全球监管格局对于评估其对药物获取的影响至关重要.
- 对监管机构的比较分析为未来的医疗保健政策提供了信息.
研究的目的:
- 在MHRA的IRP之前,分析全球药品批准的监管格局.
- 为了比较英国 (MHRA) 和主要国际机构之间的药物批准时间表.
- 评估IRP对英国获得创新药物的潜在影响.
主要方法:
- 使用2020年NICE技术简报对154种药物及其适用情况进行回顾性分析.
- 关于提交和批准日期的数据提取来自五个参考监管机构:美国FDA,欧盟EMA,日本PMDA,澳大利亚TGA和新加坡HSA.
- 监管批准时间表与英国MHRA的比较.
主要成果:
- 62%的研究药物被至少一个机构批准;38%的药物没有被任何机构批准.
- 美国食品和药物管理局 (FDA) 和欧洲药品管理局 (EMA) 的批准率最高,分别为55%和52%.
- 美国FDA的批准速度明显快于MHRA的批准 (平均快360天),而EMA的批准速度快86天.
结论:
- 在全球范围内,药品市场准入时间表存在重大差异.
- 使用FDA或EMA作为IRP下的参考监管机构可以加快英国的创新药物获取.
- 了解这些监管动态对于规划和管理IRP的影响至关重要.
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