Regulatory considerations in the development and application of biotechnology in Japan.
Regulatory considerations in the development and application of biotechnology in Japan.
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日本生物技术开发和应用的监管考虑。
DOI：
10.20506/rst.24.1.1557
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发表时间：
2005
期刊：
影响因子：
--
通讯作者：
K. Yamanouchi
中科院分区：
文献类型：
--
作者：
K. Yamanouchi
在日本，改性活生物体的开发和应用受到《保护和可持续利用生物多样性法》的管制。在不需要采取预防措施防止其向环境中扩散的情况下，使用LMOs的程序被分类为第1类；在有预防措施的情况下，使用LMOs的程序被分类为第2类。在发展阶段，风险评估是教育、文化、科学、体育和技术部的责任。详细说明了野外使用LMOs的程序，包括兽医用重组疫苗和转基因动物的程序。转基因猪的细胞、组织和器官异种移植的控制系统尚未建立。
In Japan, the development and application of living modified organisms (LMOs) are regulated under the Law Concerning the Conservation and Sustainable Use of Biological Diversity. Procedures are classified as Type 1 for the use of LMOs where no preventive measures against their dispersal into the environment are required, and Type 2 for the use of LMOs with preventive measures. During the period of development, risk assessment is the responsibility of the Ministry of Education, Culture, Science, Sports and Technology. The procedures for field use of LMOs, including recombinant vaccines for veterinary use and genetically modified animals, are described in detail. Control systems for xenotransplantation of the cells, tissues and organs of transgenic pigs are yet to be established.