Synthetic Biology Journal ›› 2021, Vol. 2 ›› Issue (5): 764-777.DOI: 10.12211/2096-8280.2021-057
• Invited Review • Previous Articles Next Articles
Zhengfu ZHOU1, Yu PANG1, Wei ZHANG1, Jin WANG1, Yongliang YAN1, Yingying ZHENG2,3, Min CHEN4, Zhihua LIAO4, Min LIN1,4
Received:
2021-05-07
Revised:
2021-07-30
Online:
2021-11-19
Published:
2021-11-19
Contact:
Min LIN
周正富1, 庞雨1, 张维1, 王劲1, 燕永亮1, 郑迎迎2,3, 陈敏4, 廖志华4, 林敏1,4
通讯作者:
林敏
作者简介:
基金资助:
CLC Number:
Zhengfu ZHOU, Yu PANG, Wei ZHANG, Jin WANG, Yongliang YAN, Yingying ZHENG, Min CHEN, Zhihua LIAO, Min LIN. Recombinant expression of milk proteins and biosynthesis of animal-free milk: analysis on related patents and trend for technology development[J]. Synthetic Biology Journal, 2021, 2(5): 764-777.
周正富, 庞雨, 张维, 王劲, 燕永亮, 郑迎迎, 陈敏, 廖志华, 林敏. 乳蛋白重组表达与人造奶生物合成:全球专利分析与技术发展趋势[J]. 合成生物学, 2021, 2(5): 764-777.
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URL: https://synbioj.cip.com.cn/EN/10.12211/2096-8280.2021-057
潜在风险 | 美国 | 欧盟 | 新加坡 |
---|---|---|---|
基因转移 | 《有毒物质控制法》第5节 | PPA 7712, 7414 2001/18/EC指令 | 《转基因生物安全指南》 |
突变与增殖 | 《有毒物质控制法》第5节 | 2001/18/EC指令 | 《生物制剂和毒素法》(24a) 《转基因生物安全指南》 |
生态系统健康和生物多样性 | 《有毒物质控制法》第5节 | PPA 7712, 7414 2001/18/EC指令2015/412指令 | 《生物制剂和毒素法》 《转基因生物安全指南》 |
商业消费 实验室/工人安全 | 《有毒物质控制法》第5节(上市后环境审查);《联邦食品、药品和化妆品法》第五章(上市前和上市后人类健康审查);美国国立卫生研究院《重组DNA分子指南》;职业安全与保健管理总署1910.1200 | 法规(EC)1829/2003 2009/41/EC指令 2000/54/EC指令 | 《生物制剂和毒素法》 《药品法》 《健康产品法》 《生物制剂和毒素法》 《转基因生物安全指南》 《工作场所安全与健康法》 |
上市前物质 事故性排放 | 美国国立卫生研究院《重组DNA分子指南》 | 2009/41/EC指令 | 《生物制剂和毒素法》 《转基因生物安全指南》 |
药物开发 | 《联邦食品、药品和化妆品法》第五章;国家环境政策法第102节 (适用于植物有害生物材料相关产品) | 法规(EC)726/2004 | 《药品法》 《健康产品法》 《生物制剂和毒素法》 |
进口、出口和装运 | 《有毒物质控制法》;《联邦食品、药品和化妆品法》第五章 | 2009/41/EC指令 法规(EC)1946/2003 | 《战略物资(管制)法》或2005年《生物制剂管制法》《转基因生物安全指南》 《生物制剂和毒素法》 |
Tab. 1 Synthetic biology regulation and governance in United States, European Union and Singapore
潜在风险 | 美国 | 欧盟 | 新加坡 |
---|---|---|---|
基因转移 | 《有毒物质控制法》第5节 | PPA 7712, 7414 2001/18/EC指令 | 《转基因生物安全指南》 |
突变与增殖 | 《有毒物质控制法》第5节 | 2001/18/EC指令 | 《生物制剂和毒素法》(24a) 《转基因生物安全指南》 |
生态系统健康和生物多样性 | 《有毒物质控制法》第5节 | PPA 7712, 7414 2001/18/EC指令2015/412指令 | 《生物制剂和毒素法》 《转基因生物安全指南》 |
商业消费 实验室/工人安全 | 《有毒物质控制法》第5节(上市后环境审查);《联邦食品、药品和化妆品法》第五章(上市前和上市后人类健康审查);美国国立卫生研究院《重组DNA分子指南》;职业安全与保健管理总署1910.1200 | 法规(EC)1829/2003 2009/41/EC指令 2000/54/EC指令 | 《生物制剂和毒素法》 《药品法》 《健康产品法》 《生物制剂和毒素法》 《转基因生物安全指南》 《工作场所安全与健康法》 |
上市前物质 事故性排放 | 美国国立卫生研究院《重组DNA分子指南》 | 2009/41/EC指令 | 《生物制剂和毒素法》 《转基因生物安全指南》 |
药物开发 | 《联邦食品、药品和化妆品法》第五章;国家环境政策法第102节 (适用于植物有害生物材料相关产品) | 法规(EC)726/2004 | 《药品法》 《健康产品法》 《生物制剂和毒素法》 |
进口、出口和装运 | 《有毒物质控制法》;《联邦食品、药品和化妆品法》第五章 | 2009/41/EC指令 法规(EC)1946/2003 | 《战略物资(管制)法》或2005年《生物制剂管制法》《转基因生物安全指南》 《生物制剂和毒素法》 |
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