Designation of Advanced Regenerative Medicine Institutions (including clinics)

Procédure

Procédure

1. 01

   Confirm the type of practice and staffing: Decide first whether you will conduct clinical research or treatment. Clinical research requires at least one physician among the principal investigator or practitioners, and treatment requires at least one physician, dentist or Korean medicine doctor as principal investigator, so check whether your medical staff can fill all four roles.

2. 02

   Check facilities and equipment: Compare item by item against Annex 1 the human cell storage room with refrigeration/freezing equipment and automatic temperature recorder, the records room with security equipment, the testing room, the treatment room (operating room, recovery room, sterilization facility) and the air-conditioning system, and organize gaps, floor plans and equipment lists.

3. 03

   Appoint staff and confirm basic training: Appoint at least one person for each of the four roles and confirm with certificates that each completed the basic training of at least 8 hours announced by the Minister before starting work. If the institution itself collects, cultures or processes human cells, appoint a separate processing staff member.

4. 04

   Prepare SOPs and IRB documents: Tailor the standard operating procedures needed for advanced regenerative medicine, such as human cell storage and record management, to the institution. Prepare the IRB registration certificate if you registered your own IRB, or the entrustment agreement if you entrust another institution's IRB.

5. 05

   Submit the application and respond to inspection: Submit the application (Form No. 1) with attachments to the Minister of Health and Welfare; the processing period is 20 days, and you supplement materials in response to inspections and correction requests. After designation, if the institution no longer meets the standards, it must notify the Minister within 10 days of becoming aware of it.

Parcours de dépôt

Parcours de dépôt

Échéances et observations

Échéances et observations

Documents de base

Documents de base

Without basic training certificates for all four roles you cannot prove the staffing standards and the application is delayed, so schedule the training before preparing the documents.