关于台湾再生医学监管的最新情况
Wan-Yu Chao1, Yi-Ting Chang1, Yueh-Tung Tsai1
1Taiwan Food and Drug Administration, Taipei, Taiwan.
Advances in experimental medicine and biology
|August 1, 2023
概括
台湾 台湾 台湾 台湾
科学领域:
- 生物技术和再生医学 生物技术和再生医学
- 监管科学 监管科学
背景情况:
- 再生医学迅速发展,需要强有力的监管框架.
- 全球趋势和当地需求推动了台湾的监管调整.
- 以前的法规将细胞和基因疗法归类为"新医疗实践"或"药品".
研究的目的:
- 概述台湾再生医学监管的演变情况.
- 描述目前的双轨监管路径.
- 讨论拟议的立法变更,以加速研发和患者获取.
主要方法:
- 台湾再生医学监管框架的历史审查.
- 分析从"新医疗实践"到"药品"监管的转变.
- 审查双轨道道路的建立和影响 (2016年) 和拟议的法案 (2022年).
主要成果:
- 自2010年以前以来,台湾的监管方法发生了重大变化.
- 2016年实施了一种双轨系统,以平衡患者获取和临床灵活性.
- 在2022年提出的新法案草案旨在进一步完善法规并促进创新.
结论:
- 台湾的再生医学监管框架已经适应了进步和患者需求.
- 目前正在进行的立法进程有望加速研发.
- 未来的法规旨在提高患者获得创新的再生疗法的机会.
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