Procedures after submitting the provision plan

Once the regenerative medicine provision plan is approved by the Regional Health Bureau Director or the Minister of Health, Labour and Welfare, the following procedures are required. Please log in to the support site for creating various application forms using the plan number, and create the necessary documents online.

• I. Regular Report on Provision Status (required to be submitted annually)
• II. Review of Changes (non-trivial)
• III. Changes (trivial)
• IV. Reporting in the Event of Disease Outbreak, etc.
• V. Suspension of Regenerative Medicine Provision, etc.
• VI. Others

I. Regarding Regular Reports on Provision Status (Committee Review Required)

From the date of submission (acceptance) of the regenerative medicine provision plan, regular reports are required every year within 90 days after the end of the period. (Form No. 3 and Form No. 4)
※ Please note that even if the number of regenerative medicine provisions is zero, regular reports on provision status are required. Also, if regenerative medicine provision is suspended, regular reports on provision status up until the suspension are required.

• ♦ Documents Required for Review

  1. Regular Report on Provision Status of Regenerative Medicine (for Committee Reporting) (Attachment Form No. 3)
  (Accessible for creation after logging in with the plan number on the various application form support site)

  2. Regular Report Format (Committee-specific document)
  For instructions on how to fill out, please refer to “Guidelines for Filling out the Regular Report on Provision Status of Regenerative Medicine, etc. (PDF file)”

• ♦ Reporting Deadline

  Every year, within 90 days after the end of the period from the submission date (acceptance date) of the regenerative medicine provision plan, regular reports are required. Prior to submitting the documents, committee review is necessary, so please ensure sufficient time for preparation. Regular Reporting Calendar (Excel file) is also available for your reference.

  《How to Use the Regular Reporting Calendar》
  Please input the submission date of the regenerative medicine provision plan (cell C12) and the plan number (cell F13).
  → The dates for the second year onwards will be automatically displayed.

II. Regarding Review of Changes (Non-trivial) (Committee Review Required)

If changes occur in the regenerative medicine provision plan, prior to that, it is necessary to undergo review by the Certified Regenerative Medicine Committee and submit a Regenerative Medicine Provision Plan Item Change Notification Form (Form No. 2) to notify the Health Bureau of the changes.

• ♦ Changes that Require Submission

  • ・Changes in provision methods that affect the safety of regenerative medicine (such as changes in responsible personnel or physicians)
  • ・When using specific cell processed products, changes in manufacturing and quality control methods of specific cell processed products that affect the safety of regenerative medicine (such as changes in cell processing methods or locations, changes in quality testing methods)
  • ・Changes related to the use of regenerative medicine products that do not comply with the approval content regarding product safety
  • ・In cases where regenerative medicine is conducted as research, changes in the implementation method of the research
  • ・Others that affect the safety of regenerative medicine

• ♦ Documents Required for Review

  • 1. Regenerative Medicine Provision Plan Item Change Notification Form (Form No. 2) (Accessible for creation after logging in with the plan number on the various application form support site)
  • 2. Attachments after the change (Only documents that have been changed need to be submitted. Please indicate the changes clearly, such as highlighting in red.)
  • 3. Comparison Table between Old and New, and Reasons for Change (We may request submission as needed)

III. Regarding Changes (Trivial) (No Committee Review Required)

If changes occur other than those mentioned in II, you must submit a Regenerative Medicine Provision Plan Trivial Change Notification Form (Form No. 3) to the Health Bureau within 10 days and notify the committee.

♦ Changes that Require Submission

・Changes not covered in II (If unsure, please inquire)
※ If a reduction in doctors or dentists providing regenerative medicine occurs, submit a Regenerative Medicine Provision Plan Item Change Notification Form (Form No. 2) after consulting the opinion of the Certified Regenerative Medicine Committee listed in the regenerative medicine provision plan. However, if the reduction in doctors or dentists is determined by the manager of the regenerative medicine provision institution to be a change other than those listed in Articles 29(1), (2), (4), or (5) of the Cabinet Order, it is acceptable to submit Form No. 3 with attached reasons for the decision. (Extracted from Q&A on the Act on Securing the Safety of Regenerative Medicine, etc. (Notification of April 4, 2016))

IV. Reporting in the Event of Disease Outbreak (Committee Review May Be Required)

When an outbreak of diseases suspected to be caused by regenerative medicine provision is discovered, it is necessary to report as follows. (Form No. 2 and Form No. 3) Additionally, in cases where specific cell processed products are used, the manufacturer and distributor of the regenerative medicine product must promptly notify the relevant authorities of the occurrence and actions taken.

V. Suspension of Regenerative Medicine Provision (No Committee Review Required)

When regenerative medicine provision is suspended, it is necessary to submit a Suspension Notification Form (Form No. 4) to the relevant Health Bureau within 10 days from the date of suspension, and promptly notify the Certified Regenerative Medicine Committee. Regular reports on provision status up until the suspension period will also be required.

Other

Based on the provisions of Article 34 of the Cabinet Order, record-keeping is required.
(It is desirable to keep records independently, but it is also acceptable to create and store records within medical records.)

♦ Recorded Items

• Address, name, gender, and date of birth of the individual receiving regenerative medicine, etc.
• Diagnosis and major symptoms
• Type of specific cell processed product used, method of administration, and other details of regenerative medicine, etc., and evaluation
• Information about the cells used in regenerative medicine, etc. (source, test results, etc.)

♦ Storage Period

• Records related to regenerative medicine, etc., using specified cell processed products or cell processed products consisting of materials similar to those of specified cell processed products shall be kept for 30 years
• For other records, the storage period is 10 years

If you forget the password for the Various Application Form Support Site, please contact the email address listed at the bottom of the site under “Inquiries about how to use the Various Application Form Support Site,” providing the necessary information.