The percentage of attempting up-to-date regenerative medicine to overcome rare and intractable diseases is increasing significantly in Korea.
The Ministry of Health and Welfare said Tuesday that the cumulative number of applications for clinical research plan review for advanced regenerative medicine totaled 125 as of the end of March 2024, with 12 applications in the first quarter of this year, doubling from six in the same period last year.
Advanced regenerative medicine is a field that can regenerate, restore, or form human body structure or function to enable fundamental treatment of diseases or provide new opportunities to treat severe, rare, and intractable diseases that are difficult to treat with existing medicines. Some countries, including the U.S., have enacted and established relevant laws and supported research.
In Korea, the “Act on Safety and Support for Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Advanced Regenerative Bio Act)” was enacted in 2019 with the goal of improving people's health and enhancing the national competitiveness of advanced regenerative medicine technology. It is being implemented.
In addition, the Advanced Regenerative Medicine and Advanced Biopharmaceutical Review Committee was formed, and a secretariat was established. The Advanced Regenerative Medicine Clinical Research System has been operated by this committee since 2021.
According to the Health and Welfare Ministry, the review committee has completed deliberations on 96 of 125 submitted research plans, of which about 44 percent, or 42 applications, were deemed “suitable for clinical research.”
"The government is promoting clinical research support projects, such as research grants to revitalize clinical research," the ministry said. "Since 2022, the Clinical Research Support Project Corps has provided 16.7 billion won ($12 million) in clinical research funding for 22 research projects, which have achieved remarkable results."
In February of this year, the Advanced Regenerative Bio Act was amended. For advanced regenerative medical technologies that have accumulated evidence of safety and efficacy through clinical studies, it will be possible to provide advanced regenerative medical treatment to patients continuously through deliberation of advanced regenerative medical treatment plans to the review committee from February next year, it added.