Minna no Tokutei Nintei Saisei Iryou Tou Iinkai/ Minna no Nintei Saisei Iryou Tou Iinkai (Preliminary)
Fukubi-kai Medical Corporation Minna no Saisei Iryou Iinkai
The “Act on Securing the Safety of Regenerative Medicine, etc.” (commonly known as the Regenerative Medicine Safety Act), which was enacted on November 25, 2014, established a framework for ensuring the safety of regenerative medicine. Under this law, institutions providing regenerative medicine, institutions reviewing regenerative medicine plans, and facilities processing specific cells are required to submit notifications or obtain approvals. This is an important step to maximize the potential of regenerative medicine while ensuring the safety of patients. Although healthcare providers and cell culture processing facilities will face new legal obligations, the aim is to enhance the safety and reliability of regenerative medicine.
Based on this law, medical institutions performing regenerative medicine are required to submit regenerative medicine supply plans taking into account the risks associated with each treatment to the Minister of Health, Labour and Welfare or the Director of the Prefectural Health Bureau.
In our corporation, we have applied for the establishment of the Special Certification Committee for Regenerative Medicine and the Certification Committee for Regenerative Medicine, and are progressing with their review.
In light of this, we welcome requests for review of regenerative medicine supply plans from all medical institutions and are accepting them at any time. We appreciate your cooperation and support for the new developments in regenerative medicine.
Procedures for Medical Institutions Intending to Provide Regenerative Medicine
- ・The administrator of the regenerative medicine supply institution is required to formulate a plan based on the regenerative medicine supply standards in advance, incorporating the opinions of the certified regenerative medicine committee, and submit it to the Minister of Health, Labour and Welfare or the Director of the Prefectural Health Bureau. This plan establishes the basic policy of the medical institution for providing regenerative medicine.
- ・If there are any changes to the plan, a new plan including the changes must be resubmitted. This is an important procedure to ensure transparency and safety in the provision of regenerative medicine.
- ・If a decision is made to terminate the plan, it is necessary to report this to the relevant authorities. The formulation, modification, and termination of the plan must all be carried out in accordance with legal procedures.
- ・Furthermore, it is legally mandated to report to the relevant authorities if there is an occurrence of a disease suspected to be caused by the provided regenerative medicine.
- ・Additionally, regular reports must be submitted annually from the date of submission of the regenerative medicine supply plan. This ensures continuous monitoring and quality control, guaranteeing the safety and effectiveness of regenerative medicine.
※ For more details, please visit the Ministry of Health, Labour and Welfare website (Regenerative Medicine).
※ Various application forms can be created on the Various Application Form Creation Support Site.
Procedures for Entities Intending to Manufacture Specific Cell Processed Products
With the enforcement of the Regenerative Medicine Safety Act, the procedures for outsourcing cell culture processing to external facilities for the purpose of providing regenerative medicine have been changed from notification-based for medical institutions to permission-based for other facilities. This change aims to ensure stricter management of the quality and safety of cell culture processing.
Entities manufacturing specific cell processed products are required to submit notifications to the Minister of Health, Labour and Welfare for each facility as specific cell processed product manufacturers. This is an important measure to ensure the safety of cell products used in regenerative medicine.
For more details, it is recommended to refer to the “Regenerative Medicine” section on the Ministry of Health, Labour and Welfare’s website. Additionally, utilizing specialized application form creation support sites for various application form creation ensures accurate and smooth procedures.
The enforcement of this law aims to support advancements in the field of regenerative medicine while establishing institutional frameworks prioritizing patient safety.
The official name of the Regenerative Medicine Committee
“Minna no Tokutei Nintei Saisei Iryou Tou Iinkai” for Type 1 and Type 2 examinations
“Minna no Nintei Saisei Iryou Tou Iinkai” for Type 3 examinations
| Business Entity | Fukubi-kai Medical Corporation |
|---|---|
| Chairperson | Hiroko Oka |
| Meeting Time | Every fourth Thursday of the month from 16:30 First Meeting: June 27th (Thursday) |
| Meeting Venue | 3/F, Uetake Building, 1-3-6 Nishi-Kanda, Chiyoda-ku, Tokyo HUMEDIT Corporation Amber |
| Address | 4/F, Zenken Plaza II, 1-3-13 Nishi-Shinjuku, Shinjuku-ku, Tokyo |
| Phone | Mobile number 080-5025-5786 (Fukubi-kai contract) |
| saisei@hiro-clinic.or.jp | |
| Certification |
※Click to enlarge. |
