Understanding ARM

Introduction to Advanced Regenerative Medicine

What Is Advanced Regenerative Medicine?

"Advanced regenerative medicine" means cell therapy, gene therapy, tissue engineering therapy and convergence therapy, provided by using human cells, etc.
to regenerate, restore, or establish a person's physical structure or function, or to treat or prevent diseases.

Reproduction, restoration, replacement by using human cells
Damaged physical function or structure
Treatment or prevention of disease

Advanced regenerative medicine

About Range of Advanced Regenerative Medicine

Therapy to treat or prevent physical/functional defects or disease affecting the life/health of patients, which is performed through clinical studies with various methods by means of transformation or culture of cells from high-risk to mid-to-low risk treatments.

Cell therapy

Cell therapy

Treatment on humans by using cells derived from humans or animals
Gene therapy

Gene therapy

Treatment by transferring genetic material into the human body or transferring into the human body the cells of humans or animals in which genetic material is transformed or implanted
Tissue engineering therapy

Tissue engineering therapy

Treatment on humans by using cells derived from humans or animals

Convergence therapy

  • 01A medical treatment that mixes at least two of the cell, gene and tissue engineering therapies
  • 02A medical treatment on human that includes gene, cell and tissue engineering therapies and a medical treatment that combines two or more from the above in physical and chemical manners

When will the advanced regenerative medical treatment system be implemented?

The "Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products (the "Advanced Regenerative Bio Act" in short)," which only allowed clinical studies, was amended in February, 2024 and entered into force in February, 2025, which now enabled the advanced regenerative medical treatments to be available even for the patients who did not participate in the clinical study within the legal standards.

What are curative effects of advanced regenerative medicine?

01
Capable of fundamental treatment of disease
02
Treatment of incurable and rare disease
03
Efficient treatment with individually tailored medicine
Performance of role of tailored therapy and increased curative effects

How can I receive treatments of advanced regenerative medicine?

The Advanced Regenerative Medicine and Advanced Biological Products Policy Committee of the Ministry of Health and Welfare deliberates and approves the treatment plan of advanced regenerative medicine, and you can receive the 'treatment of advanced regenerative medicine' at the advanced regenerative medicine implementation institution (regenerative medical institution) designated by the Minister of Health and Welfare.

Can all medical institutions engage in clinical research and treatment of advanced regenerative medicine?

Clinical research and treatments of advanced regenerative medicine can be conducted only by advanced regenerative medicine implementation institutions (regenerative medical institution).

What are advanced regenerative medicine implementation institutions?

It is a medical institution designated by the Minister of Health and Welfare after being equipped with facilities, equipment and human resources prescribed by Ordinance of the Ministry of Health and Welfare in order to perform clinical researches/treatments of advanced regenerative medicine.

  • Facilities, equipment
    Facilities,equipment
  • Human resources
    Humanresources

Designation by the Minister of Health and Welfare

Medical institution
Medical institution

Implementation of clinical researches/treatments of advanced regenerative medicine

What are cell processing establishments?

It engages in the business of recovering, examining, processing, and supplying human cells to an advanced regenerative medicine implementation institution, and it is a facility which has obtained permission from the Ministry of Food and Drug Safety.

  • Cell processing establishment
    Cell processing establishment
  • Recovery/examination/processing of human cells
    Recovery/examination/
    processing of human cells

Supply

Advanced regenerative medicine implementation institution
Advanced regenerative medicine implementation institution

Learning of useful information on advanced regenerative medicine

01What is the "Act on the Safety of and Support for Advanced Regenerative Medicine and Advanced Biological Products (the "Advanced Regenerative Bio Act" in short)"?

It is the Act enacted in August, 2019 and implemented in August, 2020 in consideration of the limitations which advanced regenerative medicine has with animal testing and clinical trial as it utilizes live cells unlike existing drug and medical technologies.

02What are the key details of the amended Advanced Regenerative Bio Act?

Since amended and enacted in February, 2025, the Advanced Regenerative Bio Act was amended with focuses on the expansion of accessibility of advanced regenerative medicine and enhancement of requirements for safety control, enabling the clinical studies on various disease through mitigation of restrictions on study subjects, and new systems are to be adopted in order to be utilized not only for clinical studies but for patient treatments.

03What is an advanced regenerative medicine implementation institution (regenerative medical institution)?

It is a medical institution designated by the Minister of Health and Welfare to safely provide advanced regenerative medicine (cell therapy, gene therapy, tissue engineering therapy, etc.) where it performs clinical studies and treatments of advanced regenerative medicine.

04What is clinical research of advanced regenerative medicine?

It is a clinical research capable of conducting the protocol of research deliberated and approved by the Advanced Regenerative Medicine and Advanced Biological Products Policy Committee in accordance with the Advanced Regenerative Bio Act after being classified from high-risk to mid-to-low-risk researches on human subjects for the purposes of expanding opportunities for treatment of diseases for patients.

05What are the differences between clinical research and treatment of advanced regenerative medicine?

A clinical research is conducted by researchers capable of performing researches without billing for expenses by recruiting study subjects in all fields as the restrictions on study subjects have been mitigated, and the treatments are medical practices where a regenerative medical institution is allowed to conduct only an approved treatment plan and the treatment subjects are limited to patients with serious/rare/incurable disease.

06Can anyone perform the treatment of advanced regenerative medicine at an advanced regenerative medicine implementation institution?

With treatments of advanced regenerative medicine, only the treatment methods of which clinical research is completed shall be allowed to perform, and the treatments may be performed only by persons who have completed the education and have been registered as required personnel as prescribed in the Advanced Regenerative Bio Act.
(Provided that in cases of low-risk treatments, they may be performed without clinical researches)

Detailed matters concerning education may be verified at the portal of advanced regenerative medicine education (http://edu.rmaf.kr).

07Are treatments of advanced regenerative medicine safe?

Treatments of advanced regenerative medicine may be performed by institutions designated as advanced regenerative medicine implementation institution (regenerative medical institution) by the Minister of Health and Welfare and approved of the treatment plan thereof in order to provide safe treatments based on strict standards and consistent management; and as the advanced regenerative medical safety management institution and the Advanced Regenerative Medicine and Advanced Biological Products Policy Committee constantly engage in safety monitoring and regular inspections, designations of advanced regenerative medicine implementation institutions shall be revoked if risks are discovered or any treatments without efficacy are performed.

08Will there be any costs arising from the treatments of advanced regenerative medicine?

Costs for treatments shall be billed, and the costs for treatments of advanced regenerative medicine reported to the advanced regenerative medical safety management institution shall be investigated by the Minister of Health and Welfare where the status of the costs analyzed shall be disclosed.

09Where can I verify the information related to advanced regenerative medicine?

Detailed information related to advanced regenerative medicine can be verified from the portal of advanced regenerative medicine (www.k-arm.go.kr). Further detailed information or any questions may be confirmed through the Regenerative Medicine Acceleration Foundation.

10What are the reporting procedures in cases of treatments given without designation of advanced regenerative medicine implementation institution or approval of conformity?

If any violation of the Advanced Regenerative Bio Act is suspected or a medical institution actually committing violations is discovered, be sure to immediately report to the Therapeutics System Support Team (ts@rmaf.kr, +82-2-6265-2242) of the Regenerative Medicine Acceleration Foundation

Information on roles by institutions related to advanced regenerative medicine

Business systems are established and operated by experts from each field of advanced regenerative medicine.

01Ministry of Health and Welfare & Disease Control and Prevention Agency

Division of Regenerative Medicine Policy, Ministry of Health and Welfare
It oversees and operates the statutes and policies of advanced regenerative medicine and iscomprehensively responsible for technical development and promotion of industry.
Advanced Regenerative Medicine and Advanced Biological Products Policy Review Committee ('Policy Committee' in short)
A committee consisting of 21 or less members, including 1 chairperson (Minister of Health and Welfare) and 1 vice chairperson (Minister of Food and Drug Safety), responsible for formulation of policies and deliberation of implementation
Advanced Regenerative Medicine and Advanced Biological Products Review Committee ('Review Committee' in short)
A committee deliberating protocols of research or treatment plans of the advanced regenerative medicine implementation institutions and responsible for deliberation of long-term follow-ups after clinical researches.
Division of Regenerative Medicine Safety Control, National Institute of Health, Korea Disease Control and Prevention Agency
It monitors the implementation to secure safety of advanced regenerative medicine, and collects and manage the data concerning survey of adverse reactions and long-term followup investigations.
Regenerative Medicine Acceleration Foundation (Advanced Regenerative Medicine Support Institution)
It researches policies and systems of advanced regenerative medicine and supports the enhancement of industrial infrastructure through planning of technical development and promotion of professional workforce.

02Ministry of Food and Drug Safety

Advanced Biopharmaceutical Task Force Team, Biopharmaceutical Policy Division
It formulates comprehensive plans concerning safety control of advanced biopharmaceutical and oversees the enactment of related statutes and improvement of systems in addition to their budges.
Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety Evaluation
An agency which reviews the quality, safety and efficacy of advanced biopharmaceutical and supports establishment and operation of examination standards and specifications.
Korea Institute of Drug Safety & Risk Management (Advanced Biopharmaceutical Regulatory Science Center)
An organization which supports long-term followup investigation of advanced biopharmaceutical and engages in management of safety information, research budgets and services.

03Legally related agencies

Advanced regenerative medicine implementation institutions ('Regenerative medical institution' in short)
A medical institution which practices advanced regenerative medicine after being designated by the Minister of Health and Welfare (Article 10 of the Advanced Regenerative Bio Act).
Advanced regenerative medicine cell processing establishments ('Cell processing establishments' in short)
An establishment which recovers human cells under approval of the Ministry of Food and Drug Safety (Article 15 of the Advanced Regenerative Bio Act) and then examines, processes and supplies to advanced regenerative medicine implementation institutions.

Clinical research/treatment procedure of advanced regenerative medicine implementation institutions

Clinical research/treatment procedure of advanced regenerative medicine implementation institutions

Cases of clinical research

  • 01During the CAR-T clinical research on leukemia patients, the team led by Professor KANG Hyeong Jin at Pediatrics Department of Seoul National University Hospital treated leukemia patients with tailored CAR-T therapy after going through gene manipulation of immunocyte for the first time in Korea and subsequently conducted a followup bone marrow examination where it was confirmed that the leukemic cells were completely disappeared.

    Source: Seoul National University Hospital, Successful treatment of leukemia with CAR-T therapy firstever produced in Korea, Medical News, May 5, 2022.

  • 02With advanced bio-convergence products grafted with stem cell and engineering technology for patients with refractory tracheal defects, artificial organ for transplant was produced through 3D bio-printing tailored for patients. Through long-term clinical researches, an artificial organ was transplanted to 1 patient with refractory tracheal defects for the first time in the world, and based on follow-up observation for 6 months following the transplant, it was announced that successful engraftment was confirmed.

    Source: Coming of era for transplant of 3D bio-printing artificial tissue/organ, The Kukmin Daily, March 11, 2024.

Major terminology of advanced regenerative medicine

Advanced regenerative medicine Cell therapy, gene therapy, tissue engineering therapy and convergence therapy implemented by using human cells in order to regenerate, recover or form human body structure or function or to treat or prevent disease; (Excluding procedures through minimal manipulations, such as simple separation, cleaning, freezing and thawing, within the scope where biological characteristics of cell/tissue maintain)
Cell Therapy Treatment on humans by using cells derived from humans or animals
Gene Therapy Treatment by transferring genetic material into the human body or transferring into the human body the cells of humans or animals in which genetic material is transformed or implanted
Tissue engineering therapy Treatment on humans by applying an engineering technology to cells or tissues derived from humans or animals for the purpose of regeneration, restoration, or replacement, etc. of tissues
Convergence therapy A medical treatment that mixes at least two of gene, cell and tissue engineering therapies or a medical treatment that falls under any one of gene, cell, tissue engineering and convergence therapies that medical devices in physical and chemical manners
High-risk therapy Clinical research that has an uncertain impact on, or poses a high risk to, human health and lives
Medium-risk therapy Clinical research that requires due attention owing to the concern over adverse effects on human health and lives
Low-risk therapy Clinical research whose effects on human health and lives are well known, posing minimal risk to human health and lives
Patient A person subject to clinical research of advanced regenerative medicine, who has a critical illness for which no alternative remedy is available or which poses a threat to his or her life, a rare disease under Subparagraph 1 of Article 2 of the Rare Disease Management Act, or other incurable diseases, etc.
Stem cells Cells capable of being divided limitlessly differentiating to other cells
Adult stem cells Stem cells derived from adult tissue that are capable of differentiating to certain tissues within human body, i.e. bone and organs
Embryonic stem cells Stem cells derived from blastocyst that are capable of differentiating to cells of all tissues
Induced pluripotent stem cell(iPSC) Stem cells developed through re-programming from adult tissue that have shapes and characteristics at the similar level with embryonic stem cells
Cell culture A process where cells separated from living organism are separated and cultured
Gene editing (Genome editing) Technology recognizing and revising a certain region of DNA within genome
Gene transfer Manipulation to express the relevant gene family by introducing gene or gene family to cells artificially

Contact information

Regenerative Medicine Acceleration Foundation
+82-2-6365-2260

Inquiry for designation procedure of advanced regenerative medicine implementation institutions
R.M. Institution Designation Team
Inquiry for supports to clinical research of advanced regenerative medicine
Clinical Research Support Team
Inquiry related to treatments of advanced regenerative medicine
Therapeutics System Support Team
Inquiry related to education of advanced regenerative medicine
Human Resources Development Team
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