在新加坡对细胞,组织和基因治疗产品的监管监督
1Advanced Therapy Products Branch, Medicinal Products Pre-Market Cluster, Health Products Regulation Group, Health Sciences Authority, Singapore, Singapore. ONG_Lee_Lee@hsa.gov.sg.
Advances in experimental medicine and biology
|August 1, 2023
概括
新加坡新加坡新加坡新加坡
科学领域:
- 生物技术和监管科学 生物技术和监管科学
背景情况:
- 新加坡卫生科学局于2021年3月1日为细胞,组织和基因治疗产品 (CTGTPs) 建立了新的监管框架.
- 该框架包括"健康产品法"下的11项附属条例,称为2021年健康产品 (CTGTP) 条例.
研究的目的:
- 描述新加坡对CTGTP的监管监督.
- 概述CTGTP监管的基于风险的方法,促进创新,同时确保安全.
主要方法:
- 基于操纵,预期用途和与其他产品的组合,CTGTPs被分为1类 (低风险) 和2类 (中度至高风险) 的分层.
- 监管控制的校准,以匹配不同CTGTP类别的独特风险概况.
主要成果:
- 对CTGTP实施一个适合目的的监管框架.
- 一种基于风险的监管方法,旨在平衡产品创新与安全,质量和有效性.
结论:
- 新加坡的监管框架支持创新型CTGTP的开发和注册.
- 该框架通过风险校准方法确保了CTGTP的安全性,质量和有效性的强有力的保障.
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