Trend: Japan's legal regulations on clinical applications of genome-editing technology on the human embryo, etc.
On May 4, the Japanese government announced plans to implement legal regulations on clinical applications of genome-editing technology on the
human embryo, etc. The government will prohibit the transfer of fertilized ova produced by genome editing into the uterus and will impose penalties for violations. This will restrict the birth of genome-edited babies. The birth of a genome-edited baby was reported in China in 2018, sparking strong international criticism and prompting legal regulations around the world. In Japan, however, only ethical guidelines have been established and no legal regulations have been implemented. It is only now that action has begun.
In Japan, the Ministry of Health, Labour and Welfare, the Ministry of Education, Culture, Sports, Science and Technology, and the Children and Families Agency formed a joint committee in 2025 to move toward legal regulations for clinical applications. The committee discussed only the handling of fertilized ova created by genome editing and drafted a bill that would prohibit the transfer of fertilized ova into the uterus and impose penalties for violations. The bill is to be submitted to the 2026 ordinary Diet session. Since the current ethical guidelines do not impose penalties for violations, the plan is to boost the effectiveness of the guidelines.
However, the legal regulations currently under consideration only restrict the transfer of fertilized ova into the uterus to prevent the birth of genome-edited babies, thus continuing to allow basic research. The government has also been discussing guidelines to regulate the creation of fertilized ova using iPS and ES cells, but the Cabinet Office's Expert Panel on Bioethics decided not to implement regulation after it approved the creation of embryos for research purposes. The guidelines basically state that embryos can be cultured for up to 14 days. The government has thus decided on a policy of recognizing the creation and manipulation of human embryos for research purposes, but has provided no grounds for doing so.
As the range of genome editing technologies, such as epigenome editing, is expanding, there is concern about the extent to which regulations will be applied. However, the government, effectively leaving the situation undetermined, states that it will stipulate the scope of such regulations by government ordinance. If this situation continues, manipulation of human embryos may be allowed to proceed unchecked in the name of research.
In September, researchers at the Arc Institute in Silicon Valley sent shockwaves around the world when they revealed in a non-peer-reviewed paper that they had used AI to create artificial (bacterio)phages (viruses that infect and replicate within bacteria) designed to kill bacteria. The full content of the paper has now been released. According to the paper, 302 different phages were created using AI, and 16 of them were confirmed to have the ability to infect and kill E. coli. The DNA of these phages is still small and the resulting phages cannot be called life forms, but there is a possibility that more life-like phages with more complex DNA will be created in the future, their danger being amplified.
The US Massachusetts Institute of Technology is also conducting research on using AI to design DNA and create phages that can infect specific bacteria. In China, the Beijing Institute of Technology has already developed an AI model that is specialized for the creation of phage DNA. Competition in this field is clearly intensifying. (Asahi Shimbun Online Edition 2026/5/4, and others.)
Organoid Farm Inc., a subsidiary of JGC Holdings, announced on April 17, that it has conducted a demonstration test of culturing cattle muscle cells in a 200-liter bioreactor. This demonstration provides a technical foundation for the production of
cultured meat. The government is currently drafting guidelines for the practical use of cell-cultured meat, and efforts to commercialize cell-cultured meat will begin in the near future. (Foovo 2026/4/20)
On April 23, Prime Minister Takaichi met with representatives of five foodtech companies at the Prime Minister's Office, expressing her willingness to create demand for
foodtech products. Those who met with PM Takaichi were representatives of the plant factories Oishii Farm and Plantec, the land-based aquaculture company FRD Japan, genome-edited fish developer Regional Fish, and agricultural drone developer Toko Tekko. The Takaichi administration is currently in the process of drawing up a roadmap for public and private sector investment, which explains why a full complement of representatives of areas promoting foodtech was present for the meeting.