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Updated: Jan 11, 2026

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Perspectives on Neuroscience
Published on: July 31, 2007
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呼吁保留CAT的专业知识和贡献,以推动欧洲的ATMP
Delphine Ammar1, Carmen Sanges2, David Henderson3
1Astellas Pharma B.V., Leiden, Netherlands.
Cytotherapy
|November 11, 2025
概括
欧洲欧洲欧洲欧洲欧洲欧洲欧洲
科学领域:
- 药品监管法规 药品监管法规 药品监管法规
- 先进疗法药物 (ATMPs) 是一种先进疗法药物.
背景情况:
- 欧盟制药立法正在进行重大改革,重塑欧洲的监管框架.
- 专业委员会如先进疗法委员会 (CAT) 可能被解散,其职能被整合到其他机构 (如PRAC,CHMP) 中.
- 这一改革是在欧洲ATMP全球临床试验活动持续十年的下降之后进行的.
研究的目的:
- 分析拟议的欧盟制药立法改革对先进治疗药物 (ATMP) 创新的潜在影响.
- 突出与删除专门的监管专业知识相关的风险,特别是ATMPs.
- 倡导多方利益相关者参与制造制药立法.
主要方法:
- 分析拟议的欧盟制药立法 (欧盟2023/0131条例,欧盟2023/0132指令).
- 欧洲ATMP临床试验活动趋势的回顾.
- 强调像T2EVOLVE这样的联盟在立法过程中的作用.
主要成果:
- 拟议的改革有可能破坏欧洲先进治疗药物 (ATMP) 领域的创新.
- 巩固专业功能可能会导致失去关键知识和专业知识.
- 在过去的十年中,ATMP临床试验活动有记录下来的下降.
结论:
- 多利益相关者联盟对于在立法改革期间保留专业知识至关重要.
- 需要强大的机制来确保ATMP开发人员持续获得监管专业知识.
- 积极参与至关重要,以防止在欧洲对ATMP创新的进一步挑战.
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