The Act on Ensuring Safety of Regenerative Medicine, etc. (Act No. 85 of 2013) came into effect on November 25, 2014, and many notifications, etc. regarding regenerative medicine have been issued.
You can check laws, notices, etc. from the link below.

• About regenerative medicine (Ministry of Health, Labor and Welfare homepage) (link to the outside site) (open with the other window)
• Document creation support site (Ministry of Health, Labor and Welfare website) (link to external site) (opens in a separate window)
• Notification on safety measures (regenerative medicine products) (PMDA website) (link to an external site) (opens in a new window)
• Enforcement of Ordinance for Enforcement of Act on Ensuring Safety of Regenerative Medicine and Ministerial Ordinance for Partial Revision of Clinical Research (PDF: 1,287KB)
  March 31, 2020 Health Policy Notification No. 0331-23 Ministry of Health, Labor and Welfare Health Policy Bureau Director
• "Handling of the Act on Ensuring the Safety of Regenerative Medicine, etc., the Order for Enforcement of the Act on Ensuring the Safety of Regenerative Medicine, etc." and Partial Revision of "Enforcement Regulations for the Clinical Research Act" (PDF: 2,320KB)
  March 31, 2020 Notification from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Revision of guidelines for regenerative medicine provision plan, etc. (PDF: 2,046KB)
  March 31, 2020 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• Regarding the revision of case studies of clinical research, etc. subject to the Clinical Research Act (Part 1), etc. (PDF: 427KB)
  March 31, 2020 Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Revision of "Points of evaluation of tumorigenicity evaluation of regenerative medicine provision plan using human pluripotent stem cells by the specified certified regenerative medicine committee" (PDF: 290KB)
  March 9, 2021 Notification from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Revision of guidelines for regenerative medicine provision plans, etc. (PDF: 179KB)
  January 28, 2021 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• "Handling of the Act on Ensuring the Safety of Regenerative Medicine, etc., the Order for Enforcement of the Act on Ensuring the Safety of Regenerative Medicine, etc." and Partial Revision of "Enforcement Regulations for the Clinical Research Act" (PDF: 720KB)
  January 28, 2021 Notice from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Enforcement of ministerial ordinance to partially revise the Ordinance for Enforcement of the Act on Ensuring Safety of Regenerative Medicine and the Ordinance for Enforcement of the Clinical Research Act (PDF: 1,511KB)
  January 28, 2021 Health Policy Notification No. 0128-2 Notification from the Director of the Health Policy Bureau, Ministry of Health, Labor and Welfare
• Revision of guidelines for regenerative medicine provision plan, etc. (PDF: 2,540KB)
  December 25, 2020 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• "Handling of the Act on Ensuring the Safety of Regenerative Medicine, etc., the Order for Enforcement of the Act on Ensuring the Safety of Regenerative Medicine, etc." About partial revision of this (PDF: 177KB)
  Full text after revision (PDF: 645KB)
  September 17, 2020 Notification from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Enforcement of ministerial ordinance to partially revise the Ordinance for Enforcement of the Act on Ensuring Safety of Regenerative Medicine (PDF: 89KB)
  June 26, 2020 Health Policy Notification No. 0626-8 Notification from the Director of the Health Policy Bureau, Ministry of Health, Labor and Welfare
• "Handling of the Act on Ensuring the Safety of Regenerative Medicine, etc., the Order for Enforcement of the Act on Ensuring the Safety of Regenerative Medicine, etc." About partial revision of this (PDF: 684KB)
  June 26, 2020 Notification from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Enforcement of ministerial ordinance to partially revise the Ordinance for Enforcement of the Act on Ensuring Safety of Regenerative Medicine (PDF: 726KB)
  May 15, 2020 Health Policy Notification No. 0515-9 Notification from the Director of the Health Policy Bureau, Ministry of Health, Labor and Welfare
• Handling of ``Act on Ensuring Safety of Regenerative Medicine, etc.,'' ``Enforcement Order of the Law on Ensuring Safety of Regenerative Medicine, etc.,'' and ``Ordinance for Enforcement of the Law on Ensuring Safety of Regenerative Medicine, etc.'' About partial revision such as "(PDF: 2,077KB)
  May 15, 2020 Health Policy Research Institute Notification No. 0515-1
• Operational Considerations in Enforcement of the Ordinance for Enforcement of the Act on Ensuring the Safety of Regenerative Medicine and the Ordinance for Partial Revision of the Ordinance for Enforcement of the Clinical Research Act (PDF: 162KB)
  April 30, 2020 Health Policy Research Institute Notification No. 0430-2 Director, Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Enforcement of ministerial ordinance to partially revise the Ordinance for Enforcement of the Act on Ensuring the Safety of Regenerative Medicine and the Ordinance for Enforcement of the Clinical Research Act (PDF: 182KB)
  April 30, 2020 Health Policy Notification No. 0430-12 Health Policy Bureau, Ministry of Health, Labor and Welfare
• Supplementary Provisions of the Ordinance for Enforcement of the Act on Ensuring the Safety of Regenerative Medicine and the Ordinance for Enforcement of the Clinical Research Act (PDF: 90KB)
  November 29, 2019 Health Policy Research Institute Notification No. 1129 No. 1 Director, Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Approach to examination of regenerative medicine using iPS cell stock for research (PDF: 87KB)
  October 29, 2019 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• Alert regarding "homologous use" stipulated in Article 1, Item 4 of the Enforcement Regulations of the Act on Ensuring Safety of Regenerative Medicine (PDF: 92KB)
  October 16, 2019 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• Revision of guidelines for regenerative medicine provision plans, etc. (PDF: 1,736KB)
  April 26, 2019 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• Conflict of interest management for regenerative medicine research (PDF: 1,116KB)
  March 20, 2019 Notification from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Revision of guidelines for regenerative medicine provision plan, etc. (PDF: 500KB)
  January 31, 2019 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• Management of conflicts of interest in clinical research under the Clinical Research Act (PDF: 2,003KB)
  November 30, 2018 Health Policy Research Bulletin No. 1130-17 Director, Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Q&A on the Act on Ensuring Safety of Regenerative Medicine (Part 4) (PDF: 293KB)
  November 30, 2018 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• Promulgation of a ministerial ordinance to partially revise the Ordinance for Enforcement of the Act on Ensuring Safety of Regenerative Medicine and the Ordinance for Enforcement of the Clinical Research Act (PDF: 4,962KB)
  November 30, 2018 Medical Policy Notification No. 130-3 Notification from the Director of the Health Policy Bureau, Ministry of Health, Labor and Welfare
• "Handling of the Act on Ensuring the Safety of Regenerative Medicine, etc., the Order for Enforcement of the Act on Ensuring the Safety of Regenerative Medicine, etc." About partial revision of this (PDF: 923KB)
  November 30, 2018 Notification from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Instructions for writing regenerative medicine provision status periodic reports, etc. (PDF: 458KB)
  October 19, 2016 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact
• About "Points of Examination of Tumorigenicity Evaluation of Regenerative Medicine Provision Plan Using Human Pluripotent Stem Cells" by Specially Authorized Committee for Regenerative Medicine (PDF: 355KB)
  June 13, 2016 Notification from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Revision of the "Guidelines on Public Health Infectious Diseases Associated with Xenotransplantation" (PDF: 459KB)
  June 13, 2016 Notification from the Director of Research and Development Promotion Division, Health Policy Bureau, Ministry of Health, Labor and Welfare
• Q&A on the Act on Ensuring Safety of Regenerative Medicine (Part 3) (PDF: 108KB)
  April 4, 2016 Ministry of Health, Labor and Welfare Health Policy Bureau Research and Development Promotion Division Office Contact