Japan's health ministry has opened a public comment round on a draft cabinet order that redraws what counts as a regenerative medicine technique under the country's safety law. The draft takes human sperm, unfertilized eggs and the embryos formed when the two meet out of the law's scope, and includes stem-cell lines derived from them.
What the draft changes
The Ministry of Health, Labour and Welfare's research and development policy division drafted an amendment to the enforcement order of the Act on the Safety of Regenerative Medicine, etc. (Act No. 85 of 2013). The act sets the measures that providers of regenerative medicine must take, and the order defines which techniques fall under it.
Under the draft, the following would be excluded from the act's scope:
- human sperm or unfertilized eggs;
- embryos produced by fertilizing a human sperm with an unfertilized egg.
The following would be included:
- embryonic stem cells established from human sperm and unfertilized eggs, whether taken from a person or made from a person's somatic cells;
- embryonic stem cells established from sperm and eggs that were themselves made from those stem cells;
- somatic cells made from such stem cells, and the induced pluripotent stem cells, tissue stem cells and further somatic cells derived from them.
The stated reason
The ministry ties the change to a report issued on 26 August 2025 by the bioethics panel of the Council for Science, Technology and Innovation, on creating human embryos using human germ cells derived from stem cells. The report set a policy that fertilization of stem-cell-derived germ cells should be permitted under certain conditions. The ministry says the scope of the regenerative medicine technique definition must be amended in light of that.
Timing
The ministry plans to promulgate the order in late March 2027, with effect from 24 July 2027. That date is set to match the start of the Act on the Regulation of Handling of Human Genome-Edited Embryos and the Like (Act No. 70 of 2026), which takes effect one year after its promulgation. The ministry says it will also review a notification on fertilization of stem-cell-derived germ cells under certain conditions, in line with that law's start. The overview gives no details of those conditions.
How to comment
The comment period runs from 6 November to 5 December 2026. Submissions must be in Japanese, with reasons, through the e-Gov comment form, by email to the ministry, or by post to its Kasumigaseki office. Individual replies will not be given, and comments may be published apart from contact details.