To implement a plan for the provision of first-class regenerative medicine, the provider is required to submit a plan to the Minister of Health, Labor and Welfare after receiving opinions from the Specified Committee for Approved Regenerative Medicine. The Act sets 90 days as the restriction period for the implementation during which the Minister of Health, Labor and Welfare checks the safety of the plan after consulting the Health Science Council. The Act allows the Minister to order modifications to the plan if the plan does not conform to the standards for safety. That is to say, the notable points of the Act are (1) examination by the Specified Committee for Approved Regenerative Medicine, (2) submission of the plan for provision of regenerative medicine to the Minister, and (3) implementation after a 90-day restriction period (central examination by the Regenerative Medicine Examination Committee of the Health Science Council), and they were not significantly changed from the examination under the Guidelines for Clinical Research Using Human Stem Cells. This is a virtual approval system. To implement a plan for provision of second-class regenerative medicine, the provider is required to submit a plan to the Minister of Health, Labor and Welfare after receiving opinions from the Specified Committee for Approved Regenerative Medicine. The system for second-class regenerative medicine required only the abovementioned (1) and (2) and represents a relaxed version of the current double check system. It is a virtual registration system. On the other hand, securing good examination qualities of the Specified Committee for Approved Regenerative Medicine is an urgent subject; therefore, committees with low examination standards will be eliminated in actual practice. To implement a plan for provision of third-class regenerative medicine, the provider is required to submit a plan to the Minister of Health, Labor and Welfare after receiving opinions from the Committee for Approved Regenerative Medicine. Each medical institution is allowed to constitute the Committee for Approved Regenerative Medicine; therefore, it is very predictable that the examination qualities of such committees will differ greatly. Securing proper examination quality is considered to have a decisive influence on the future of regenerative medicine. The Specified Committee for Approved Regenerative Medicine is defined as a committee that possesses a superior examination capability and objectivity and is not assumed that every medical organization will have it. Specified Committees are assumed to be operated in the way similar to that of the central IRB and to undertake an examination as an onerous contract.

The Act defined measures for the proper provision of regenerative medicine, such as informed consent and measures for personal information protection, and the Act also requires prompt reporting of an adverse event to the Minister of Health, Labor and Welfare on which the Minister takes the needed precautions after consulting the Health Science Council. These are compensating measures for the immaturity of current regenerative medicine. The Act allows the Minister of Health, Labor and Welfare to issue an improvement order when safety measures are required, to restrict provision of regenerative medicine if the provider disobeys the improvement order, and to order emergency measures, such as suspension of the provision of regenerative medicine, when protection against the outbreak and spread of health and hygiene hazards is required. The new medical service law grants the authorities the power to conduct inspections under entrance in consideration of past accidents, including fatal ones, in non-covered medical services.