Ministry of Health and Welfare Specifies Criteria for Intractable Diseases and Eases Non-Clinical Data Requirements
Treatment Now Permitted Using Overseas Clinical Data
In order to enable patients with rare and intractable diseases to receive advanced regenerative medicine treatments more quickly, the government will lower barriers to entry for clinical research and significantly improve regulations to allow the use of overseas clinical data in domestic treatments.
The Ministry of Health and Welfare announced on the 28th that, as a follow-up to the "2nd Core Regulation Rationalization Strategy Meeting" held last October, it has prepared regulatory improvement measures for advanced regenerative medicine and reported them to the Policy Committee on Advanced Regenerative Medicine and Advanced Biopharmaceuticals.
First, the government will clarify and specify the criteria for intractable diseases to enhance predictability for researchers. Although a system for advanced regenerative medicine treatments for serious, rare, and intractable diseases was introduced in February this year, there have been concerns that the lack of a clear definition for intractable diseases made it difficult for researchers to determine in advance whether treatment was possible.
To address this, instead of simply listing disease names, the government has presented specific criteria that allow for individual assessment of situations requiring treatment. In addition, it has developed the "Review Guide and Preparation Guidelines for Advanced Regenerative Medicine Treatment Plans," which includes examples of intractable disease cases submitted to the existing review committee and interpretative examples. This will be implemented starting January 1 next year.
The practice of requiring the same level of non-clinical trial data for medium- and low-risk clinical research as for high-risk research will also be improved. Going forward, unnecessary data will be excluded based on cell type-such as stem cells, immune cells, and somatic cells-and existing research literature can be used as substitutes, while meaningless tests may be omitted through a differentiated approach.
The use of overseas clinical results will also be expanded. Currently, advanced regenerative medicine treatments can only be linked after safety and efficacy have been confirmed through domestic clinical research, which results in long delays before actual treatment. To address this, the government plans to expand the "planned regulatory sandbox" from next year, allowing domestic treatment plans to be reviewed based on sufficient overseas clinical trial or research results.
Additionally, the government will lead clinical research in areas with high demand for overseas medical travel, such as degenerative arthritis and chronic pain. In March next year, a multicenter clinical research call will be conducted to verify the safety and efficacy of autologous stem cell and immune cell culture therapies, aiming to meet unmet medical needs domestically. To respond to the increasing demand for research and treatment, the government also plans to strengthen administrative support by expanding review personnel and enlarging the pool of expert committee members.
Jung Kyung-sil, Director of Health and Medical Policy at the Ministry of Health and Welfare, stated, "Through regulatory improvements, we will invigorate clinical research, accelerate the implementation of treatments, and promote the development of innovative technologies, thereby expanding treatment opportunities for patients."
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