治疗过敏原条例 (TAO):最后一段时间
Vera Mahler1, Diana Hartenstein1, Iris Lauer1
1Allergology Division.
Allergologie select
|November 20, 2025
概括
治疗过敏原条例 (TAO) 将过敏原免疫疗法 (AIT) 产品转换为授权的状态. AIT产品的可销售性取决于到2026年成功的营销许可申请.
科学领域:
- 免疫学 免疫学 免疫学
- 药理学 药理学是指药理学的学科.
- 监管事务 监管事务
背景情况:
- 德国的治疗过敏原条例 (TAO) 促进过敏原免疫疗法 (AIT) 产品从命名患者产品 (NPP) 迁移到授权市场地位.
- 该条例特别针对来自家用粉尘,蜜蜂毒,黄蜂毒,特定花粉 (草,,,,) 和混合过敏原组的常见过敏的AIT产品.
研究的目的:
- 概述TAO下的AIT产品的监管途径和当前状态.
- 通知利益相关者即将到来的截止日期以及对产品可销售性的影响.
主要方法:
- 对治疗过敏原条例 (TAO) 条款的审查.
- 对正在经营许可程序的AIT产品市场现状的分析.
- 对AIT产品的撤回和批准时间表的监控.
主要成果:
- 截至2025年8月8日,根据TAO的过渡条款,40种AIT产品仍然可以销售.
- 制药公司已经开始撤销8种AIT产品,截止日期为2025年底和2026年初.
- 保罗-埃里希研究所正在评估更新的营销许可申请 (MAA),对于剩余的32种产品尚未做出决定.
结论:
- 根据TAO,AIT产品的可销售性取决于成功获得营销许可.
- 拒绝MAA的结果是立即退出市场,没有抛售期.
- 成功的MAA授予永久化产品的可销售性,确保患者继续获得AIT治疗.
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