转基因动物产品:从法规到应用
Carlos Fajardo1,2, Marta Macedo2,3, Tonka Buha2,3,4
1Department of Biology, Faculty of Marine and Environmental Sciences, Instituto Universitario de Investigación Marina (INMAR), Campus de Excelencia Internacional del Mar (CEI·MAR), University of Cadiz (UCA), 11510 Puerto Real, Spain.
Animals : an open access journal from MDPI
|June 13, 2025
概括
转基因动物提供了创新的解决方案,但与转基因植物相比,它们面临着公众接受的挑战. 本次审查涵盖批准的转基因动物产品及其监管途径.
科学领域:
- 生物技术和基因工程 生物技术和基因工程
- 动物科学动物科学
- 监管科学是一种监管科学.
背景情况:
- 生物技术的进步使得转基因动物可以用于农业和医学.
- 转基因动物产品面临的公众接受度低于转基因植物产品.
- 监管框架和公众的看法对于转基因动物的商业化至关重要.
研究的目的:
- 审查已批准的转基因和基因编辑动物衍生物产品.
- 讨论转基因动物的监管背景和基于风险的评估.
- 检查美国 (FDA) 和全球的转基因动物批准.
主要方法:
- 对已批准的转基因动物产品进行文献审查.
- 分析FDA和其他司法管辖区的监管文件和指导方针.
- 基于风险的评估策略的个案评估.
主要成果:
- 几种转基因和基因编辑动物产品已被FDA批准.
- 监管部门的批准涉及基于风险的严格个案评估.
- 展示了来自其他全球司法管辖区批准的转基因动物的例子.
结论:
- 转基因动物对农业和医学具有重大潜力.
- 导航监管格局和公众看法是成功商业化的关键.
- 该审查提供了对全球当前批准和监管方法的见解.
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