Southeast Regional Radiation Medical Center Designated as an 'Advanced Regenerative Medicine Implementation Institution'

Rapid Clinical Research in Advanced Regenerative Medicine

Increased Patient Access and Benefits for the Latest Treatments

The Dongnam Regional Radiation Medicine Institute was recently designated as an Advanced Regenerative Medicine Implementation Institution by the Ministry of Health and Welfare.

According to the enforcement of the "Advanced Regenerative Bio Act" in August 2020, medical institutions intending to conduct clinical research on advanced regenerative medicine (cell, gene, tissue, and convergent therapies) must be equipped with facilities, equipment, personnel, and standard operating procedures in accordance with the regulations on the safety and support of advanced regenerative medicine. They must undergo document verification and on-site inspection to be designated as an advanced regenerative medicine implementation institution.

With the recent designation of the Dongnam Regional Radiation Medicine Institute as an advanced regenerative medicine implementation institution, it can now receive various policy supports such as incorporation into medical quality evaluation indicators, expedited and combined review of high-risk clinical research, and clinical research funding support. Additionally, the institute received certification for its cell processing facility from the Ministry of Food and Drug Safety in 2022, enabling medical staff with expertise in clinical research involving cell collection, separation, and culture to participate. It is an institution capable of conducting scientific and ethical clinical research that meets the latest standards.

In particular, as Busan City, where the institute is located, has established related policy systems and enacted ordinances to create high added value in advanced regenerative medicine, the role of the Dongnam Regional Radiation Medicine Institute is expected to expand in the future.

Furthermore, by forming a consultative body led by Busan City that connects advanced regenerative medicine implementation institutions, efforts are being made to promote the joint development of advanced regenerative medicine within the region and to build an innovative ecosystem.

Lee Chang-hoon, Director of the Dongnam Regional Radiation Medicine Institute, stated, “To expand treatment opportunities for patients in advanced regenerative medicine and strengthen the foundation for research and industrial development, the 'Advanced Regenerative Bio Act,' which includes the introduction of advanced regenerative medicine therapeutics and the expansion of clinical research subject scope, is scheduled to be enforced in February next year. The Dongnam Regional Radiation Medicine Institute will do its best to align with these policy directions by prioritizing patient safety, expanding treatment opportunities, and enhancing patient accessibility in the field of advanced regenerative medicine.”

Southeast Regional Radiation Medical Center.

This content was produced with the assistance of AI translation services.