On February 19, an expert committee of the Ministry of Health, Labour and Welfare (MHLW) approved two regenerative medicine products that use iPS cells. On the following day, MHLW Minister Ueno said that the new drugs would be officially approved in early March. Currently, in Japan, venture companies launched by universities are actively moving toward the practical application of iPS cells, but as no products have been approved thus far, these are the first approvals.

One of the two regenerative medicine products using iPS cells to be approved is a cardiac muscle sheet developed by Cuorips, a startup company from The University of Osaka, which submitted an application for manufacture and sale to MHLW on April 8 last year. This was the first application for a product derived from iPS cells for patients with severe heart failure. Due to the paucity of data, it was thought likely that the approval would be provisional, but full approval has now been granted. As a result, it is could possibly be said that the approval has been granted without sufficient confirmation of safety.

Regarding the other iPS cell product, Professor Atsushi Takahashi and his colleagues at Kyoto University's Center for iPS Cell Research and Application announced in the April 16, 2025 issue of Nature that they had confirmed the safety and efficacy of nerve cells derived from iPS cells by transplanting them into seven patients with Parkinson's disease in a clinical trial. In response, Sumitomo Pharma, which had been promoting the commercialization of the treatment, applied to the Ministry of Health, Labour and Welfare for approval on August 5 last year. It could also be said that this approval was granted in a very rushed manner.

After approval, the prices of the treatments will be determined and the products will appear on the market. Currently, a variety of iPS cell products are being developed, and it is possible that these approvals will lead to their successive, rapid appearance. There are concerns that the rush to approve new treatments may lead to new harmful effects.

The high-sugar tomato developed by the genome-editing technology of Gra&Green Inc., a venture company launched by Nagoya University, is about to hit the market. The company notified the Ministry of Agriculture, Forestry and Fisheries and the Consumer Affairs Agency of the tomato last year. Farmers in Chiba Prefecture have already started growing it, and it is scheduled to go on trial sale from this summer. This tomato going on sale will mean that there is more than one genome-edited tomato on the market, following commercialization of the high-GABA tomato. (Wedge 2026/2/10)

On February 24, the Consumer Affairs Agency considered the registration of a genome-edited "reduced browning" banana developed by Britain's Tropic Biosciences Ltd, at a closed meeting of the Food Sanitation Council's subcommittee on newly developed foods. In this banana, the gene for the enzyme polyphenol oxidase, which causes browning, has been knocked out. This enzyme has the important role of protecting the fruit from oxidation, and the gene responsible for this has been disrupted. The banana was registered in the Philippines on June 21, 2024, and the company is currently in the process of registering it worldwide. The company is also developing an "prolonged shelf life" banana in which a gene involved in ethylene production has been disrupted, and this will likely be registered in due course.

The Consumers Union of Japan and other organizations have submitted a letter of inquiry to the mayor of Akune City, Kagoshima Prefecture, concerning the city's partnership with Regional Fish Institute, Ltd., a company that develops, farms, and sells genome-edited fish. The letter asks the mayor to disclose the details of the agreement and the contents of discussions with the city council and fishery industry officials, as well as requesting information about how the company will handle the genome-edited fish.

Setsuro Tech, Ltd., a company based in Tokushima City that contracts for production of genome-edited crops, has raised 320 million yen to expand its contract business manufacturing monoclonal antibodies for pharmaceuticals. The company has thus far been producing and providing monoclonal antibodies using a DNA immunization method developed by the Cell Engineering Corporation, but now appears to be aiming for an expansion of that business. (Nikkei Biotech Online Edition 2026/2/4)

On February 5, the Consumer Affairs Agency held a meeting of the Food Sanitation Council's subcommittee on newly developed foods and presented an outline of draft guidelines for manufacturing and marketing cell-cultured foods. Relevant issues and points related to cell procurement, food production, and food processing will be presented, and these issues will be organized and compiled into guidelines. If things continue to move forward in this way, the guidelines will be compiled by the end of this year, raising the possibility that cell-cultured foods will sooner or later appear on the market.

The Ministry of Economy, Trade and Industry (METI) held the first meeting of its working group on "the synthetic biology and biotechnology sector" on February 3. The meeting was one of 17 strategic fields for Japan's growth strategy proposed by the Takaichi administration. The participants gave opinions on issues and measures for proposals toward the creation of a roadmap and a strengthening of the industrial base. Growth strategies for pharmaceuticals, food and other fields are expected to be compiled by this summer.