Perspectives on Stem Cell-Based Regenerative Medicine with a Particular Emphasis on Mesenchymal Stem Cell Therapy

1-2. Outline of the Act on the Safety of Regenerative MedicineClarify the measures that shall be implemented by organizations who are going to provide regenerative medicine and stipulate the system, etc., for approval of manufacturing, etc., of specified cell products, for the purpose of swift and safe provision, etc., of regenerative medicine Aim Implementation date 1. Classification of regenerative medicineRegenerative medicine is classified into 3 categories, "Class I Regenerative medicine", "Class II Regenerative medicine", and "Class III Regenerative medicine" depending on the degree of effects on human life and health, and necessary procedures are stipulated for each category.2. Procedures pertaining to provision of regenerative medicine o Class I Regenerative medicine: Submit a provision plan to the Minister of Health, Labour and Welfare (HLW) after hearing opinions of the Certified Special Committee for Regenerative Medicine, and then implement.A certain period of restricted implementation period will be imposed, and the Minister of HLW will confirm the safety, etc., by hearing opinions of the Health Science Council within the period.The Minister orders change of the plan if there is nonconformity to the standards of safety, etc. o Class II Regenerative medicine: Submit a provision plan to the Minister of HLW after hearing opinions of the Certified Special Committee for Regenerative Medicine, and then implement.o Class III Regenerative medicine: Submit a provision plan to the Minister of HLW after hearing opinions of the Certified Committee for Regenerative Medicine, and then implement.* The Certified Special Committee for Regenerative Medicine has a specifically advanced investigation capability and objectivity.* Certain requirements on the facility and personnel will be imposed on medical institutions that provide Class I Regenerative medicine or Class II Regenerative medicine. Measures for appropriate provision, etc.o Measures for informed consent, protection of personal information, etc., are stipulated.o Any emergence of disease, etc., shall be reported to the Minister of HLW.The Minister will take necessary measures with hearing opinions of the Health Science Council.o An order for improvement will be issued if necessary for ensuring the safety etc.If violation to the order for improvement is identified, provision of regenerative medicine will be restricted.Emergency measures such as temporary suspension of provision of regenerative medicine will be taken if necessary for prevention of outbreak or expansion of hygiene hazards.o The Minister of HLW shall periodically gather information on the implementation status of regenerative medicine and publicly announce its outline.