Advanced Regenerative Medicine Institution Designation: Documents and Standards — 4 Required Staff Roles, 20-Day Processing

Procedure

1. 1. Decide the type of practice and confirm eligibility

   First decide whether you will conduct advanced regenerative medicine clinical research or advanced regenerative medicine treatment. For clinical research, at least 1 physician must be among the lead investigator or investigators, and for treatment, at least 1 physician, dentist or Korean medicine doctor must be among the lead investigators. Any medical institution except a midwifery clinic, including clinic-level institutions, can apply.

2. 2. Prepare facilities and equipment

   Set up a human cell storage room with refrigeration and freezing equipment and an automatic temperature recorder, a records room with computer and security equipment, and a testing room for blood tests and similar tests. The procedure area consists of an operating room, a recovery room and sterilization facilities, and an air conditioning system is installed to prevent contamination of these facilities and maintain temperature and humidity.

3. 3. Appoint staff and complete basic training

   Appoint at least 1 each of a lead investigator, investigator, human cell manager and information manager. These staff must complete at least 8 hours of basic training set by the Minister of Health and Welfare before starting work, and then at least 8 hours of training every 2 years. If the institution directly collects, cultures or processes human cells, a separate processing staff member is required.

4. 4. Prepare SOPs and IRB documents

   Prepare standard operating procedures needed for advanced regenerative medicine clinical research or treatment, tailored to the institution. If the institution has registered its own institutional review board, prepare the registration certificate; if it entrusts the work to another institution, prepare the entrustment agreement.

5. 5. Apply for designation and manage after designation

   Submit the designation application with the attachments to the Minister of Health and Welfare; the processing period is 20 days, and an on-site inspection may be conducted to check whether the application meets the standards. Once designated, a designation certificate is issued and the institution's name and other details are announced. If the institution no longer meets the designation standards, it must notify the Minister of Health and Welfare within 10 days of becoming aware of it.

Required documents

• Application for designation as an advanced regenerative medicine institution (Form No. 1 of the Enforcement Rule on Safety of and Support for Advanced Regenerative Medicine)
• Copy of the medical institution establishment report certificate or establishment permit
• Documents proving that facility, equipment and staff standards are met (including confirmation of basic training for each staff member)
• Standard operating procedures needed for advanced regenerative medicine clinical research or treatment
• Institutional review board entrustment agreement or institutional review board registration certificate
• Letter of authorization (when submitted by a representative)

Fees

Typically several hundred thousand won to several million won across the industry · We will advise after consultation depending on the type of practice (clinical research or treatment), the scope of SOP preparation and the number of supplementation rounds. Government fees are separate.

See fees and official charges for this service →

Legal basis and review date

• Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products, Article 2
• Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products, Article 10
• Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products, Article 12
• Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products, Article 12-2
• Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products, Article 42
• Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products, Article 57
• Enforcement Rule on Safety of and Support for Advanced Regenerative Medicine, Article 3
• Enforcement Rule on Safety of and Support for Advanced Regenerative Medicine, Annex 1
• Enforcement Rule on Safety of and Support for Advanced Regenerative Medicine, Annex 1-2
• Enforcement Rule on Safety of and Support for Advanced Regenerative Medicine, Form No. 1

Checked against the statutes on 2026-10-08

Statutes and public notices change, so each case needs to be checked individually. Statute titles are given in English for reference. The Korean statutes are the authoritative text.

Check these first

• Performing advanced regenerative medicine before designation or differently from the reviewed plan is punishable by up to 5 years in prison or a fine of up to 50,000,000 won, and designation obtained by false means will be cancelled.
• Staff training must be completed before the designation application, so check the training schedule first and then prepare the documents.

Frequently asked questions