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Product title :

Regulatory considerations in the development and application of biotechnology in Japan

Author(s) : K. Yamanouchi

Summary :

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.

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