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波兰的监管制度涉及到ATMP医院豁免

Jan Pachocki¹, Frances Verter²

¹Consultant, Warsaw, Poland.

Frontiers in immunology

|May 28, 2024

概括

波兰波兰波兰波兰

科学领域:

监管科学监管科学
卫生政策卫生政策
生物技术是生物技术.

背景情况:

根据医院豁免 (ATMP-HE) 对先进治疗药物 (ATMP) 的监管框架对于患者获得创新治疗至关重要.
波兰对ATMP-HE法规的实施在2018年至2023年之间发生了显著的发展.
介质细胞干细胞 (MSC) 是波兰主要使用的ATMP-HE疗法.

研究的目的:

阐明波兰ATMP-HE目前的监管环境.
分析波兰ATMP-HE法规对制造商,医生和患者的影响.
将波兰的ATMP-HE实践与其他欧盟成员国进行比较.

主要方法:

翻译和分析有关ATMP-HE的波兰相关立法.
利益相关者分析检查制造商,医生和患者的观点.
在欧盟背景下对波兰的ATMP-HE系统进行比较评估.

主要成果:

波兰ATMP-HE法规从2018年至2023年进行了实质性修订.
介质细胞干细胞 (MSC) 疗法占波兰ATMP-HE治疗的大部分.
波兰的ATMP-HE实施符合欧盟的一般做法,但在医疗保健资金方面面临挑战.

结论:

由于人均支出较低,波兰的ATMP-HE需要在国家医疗保健系统之外获得资金.
该系统为未满足的医疗需求提供实验性疗法的能力正面临压力.
平衡利益相关者的利益是实现ATMP-HE立法最初意图的关键.

关键词:

先进疗法药物 (ATMPs) 是指先进疗法药物.细胞和基因疗法 (CGT)医院豁免 (HE) 的情况.介质细胞 stromal 细胞 (MSC)国家许可条款国家许可条款监管事务监管事务风险 - 收益关系未经证实的细胞和基因干预.

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