High-Risk 'Advanced Regenerative Medicine' Clinical Plans Can Now Be Reviewed Quickly

It is expected that rapid review of high-risk advanced regenerative medical clinical research plans will become possible. This is anticipated to serve as an opportunity to expand treatment options for patients in line with the development of advanced pharmaceuticals.

Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety, is presiding over the "1st Advanced Regenerative Medicine and Advanced Biopharmaceutical Policy Deliberation Committee" meeting on the 12th.
[Photo by Ministry of Food and Drug Safety]

On the 12th, the government held the "2023 1st Advanced Regenerative Medicine and Advanced Biopharmaceutical Policy Deliberation Committee" meeting at the Korea Press Center in Jung-gu, Seoul, chaired by Oh Yu-kyung, Commissioner of the Ministry of Food and Drug Safety.

The Policy Deliberation Committee is composed of 21 members, including officials from the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, and private experts, and serves as a body to deliberate on major matters related to whole-of-government support policies and clinical research in the fields of advanced regenerative medicine and advanced biopharmaceuticals.

At this Policy Deliberation Committee meeting, four agenda items were discussed: ▲ measures to lift designation of long-term follow-up survey targets for advanced biopharmaceuticals ▲ operational improvements to the approval system for high-risk advanced regenerative medical clinical research plans ▲ promotion plans for the scope and classification review of advanced regenerative medicine ▲ and the composition and operation plans for the 2nd Advanced Regenerative Medicine and Advanced Biopharmaceutical Deliberation Committee.

The Ministry of Food and Drug Safety reported on the "Measures to Lift Designation of Long-term Follow-up Survey Targets," which includes criteria for judging the necessity of continuing follow-up surveys, timing for applying for lifting the designation, documents to be submitted when applying for lifting the designation, and review procedures. Long-term follow-up surveys are investigations conducted over a long period (5 to 30 years) after administration to monitor for adverse events in patients who have received advanced biopharmaceuticals containing stem cells or genetic materials.

Additionally, they reported on the promotion of notices for introducing rapid and combined review procedures for high-risk advanced regenerative medical clinical research plans and establishing grounds for close consultation between the Ministry of Health and Welfare and the Ministry of Food and Drug Safety during the review and approval process.

The Ministry of Health and Welfare plans to review at the Policy Deliberation Committee whether new technologies such as in-vivo gene therapy can be included within the scope of advanced regenerative medicine, considering domestic and international laws and technical characteristics. They also reported plans to establish criteria for reassessing and reclassifying clinical research risk levels and to promote deliberation by the Policy Deliberation Committee.

Commissioner Oh Yu-kyung of the Ministry of Food and Drug Safety emphasized, "By proactively reflecting technological advancements in the field of advanced regenerative medicine, we will be able to expand treatment opportunities for patients," adding, "It is necessary to operate the system rationally while fully embracing the purpose of the 'Advanced Regenerative Bio Act' to provide treatment opportunities for patients with rare and intractable diseases."

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