High-Risk Clinical Research Approval Process to Eliminate Dual Regulation

[Asia Economy Reporter Chunhee Lee] The time required for final approval is expected to be shortened as additional review procedures by authorities for high-risk clinical research are conducted in advance.

On the morning of the 30th, the government held the 4th Advanced Regenerative Medicine and Advanced Biopharmaceutical Policy Deliberation Committee chaired by Kim Gang-rip, Commissioner of the Ministry of Food and Drug Safety (MFDS), and deliberated on the "Improvement Plan for the Review and Approval Procedures of High-Risk Clinical Research" containing such details.

High-risk clinical research refers to clinical studies where the impact on human life and health is uncertain or the risk level is high. Until now, to approve a high-risk clinical research plan, even if the review committee resolved its suitability based on the review results of specialized committees by field, final approval had to be obtained through an additional review by the MFDS. During this additional review process, requests for supplementary materials and other factors have prolonged the time to final approval, causing delays in the start of research.

Accordingly, going forward, specialized committees and the MFDS will conduct preliminary reviews before the review committee deliberates on the clinical research plan, and at the final deliberation by the review committee, all these review results will be considered to make the final decision.

The government stated, "With this procedural improvement, the period until the final approval of high-risk clinical research plans will be shortened, and research is expected to start at an appropriate time," adding, "From the researchers' perspective, since additional reviews separated from the review committee deliberation will no longer occur, predictability of administrative procedures will be secured and unnecessary burdens will disappear."

At the committee meeting, detailed implementation plans for the '2022 Advanced Bio Implementation Plan' were also disclosed. This contains the second-year detailed implementation plans by ministries for the total of 46 policy tasks in the 1st Basic Plan for Advanced Regenerative Medicine and Advanced Biopharmaceuticals announced last January. Among the 40 tasks currently underway from this year, four new tasks will be added next year: ▲ Diversification of treatment cost support programs ▲ Establishment of a social discussion foundation on regenerative medicine issues ▲ Building a cooperation system for overseas innovative technology patents and technical know-how ▲ Establishment of tissue engineering research and manufacturing infrastructure.

The Ministry of Health and Welfare plans to form a social public discussion body on advanced regenerative medicine and biopharmaceuticals alongside the improvement of high-risk clinical research review and approval procedures, to conduct social discussions for institutional improvements in regenerative medicine fields such as the introduction of regenerative medical procedures and treatment cost support.

The MFDS will prepare linkage measures between clinical research and biopharmaceutical approval reviews. The Korea Disease Control and Prevention Agency will begin safety monitoring following the full-scale clinical research and will also conduct safety management system inspections of advanced regenerative medical institutions.

The Ministry of Science and ICT will select new tasks for regenerative medicine technology and support research and development (R&D) through the "Pan-Ministerial Regenerative Medicine Technology Development Project." The Ministry of Trade, Industry and Energy will conduct a preliminary feasibility study for the advanced biopharmaceutical universal production system technology development project.

Kim Gang-rip, Commissioner of the MFDS, said, "I hope that each ministry will proceed with policy tasks including new tasks for next year as planned, and through continuous institutional improvements that meet the demands of researchers, companies, and patients, we can lay the foundation for becoming a leading nation in regenerative medicine."

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