(SLA-051) Role of the Regulatory Science Center in the Safety Management of Advanced Biological Products in Korea

Background: Advanced biological products (ABPs), including cell and gene therapy products and tissue engineering products, differ from commonly used chemical drugs in that they may remain in the human body for extended periods and cause delayed adverse events. Due to these characteristics, the importance of long-term follow-up (LTFU) has been emphasized in various aspects with the development of ABPs. In South Korea, “Advanced Regenerative Medicine and Advanced Biological Products Safety and Support Act” was enacted in 2020 to ensure the long-term safety of ABPs.

Objectives: We aim to describe the role of South Korea’s Regulatory Science Center in ensuring the long-term safety and risk management of ABPs and the detailed implementation of a LTFU system.

Methods: We reviewed the role of the Regulatory Science Center, which is part of the Korea Institute of Drug Safety and Risk Management (KIDS), in overseeing the safety management of ABPs. Additionally, we examined the relevant laws and the LTFU system established for these products.

Results: The KIDS has been designated as the Regulatory Science Center for ABPs and plays a key role in supporting the LTFU system. At the clinical trial plan approval or product approval stage, the LTFU system is initiated by Korea Ministry of Food and Drug Safety (MFDS), which designates drugs that require LTFU and informs the respective companies and the Regulatory Science Center. Companies then submit LTFU plans to monitor the safety of the ABPs for up to 30 years, depending on the product type. The Regulatory Science Center evaluates these plans and monitors their implementation annually. To estimate how ABPs are supplied and administered to patients, the center collect supply, sales and administration records. Furthermore, the center collects and analyzes safety data, investigating serious adverse events and delayed adverse events. From 2020 to 2024, approximately 280 LTFU plans and annual reports have been reviewed, collecting and evaluating safety information on ABPs. To stay up to date with global trends, the Regulatory Science Center gathers information from international sources and publishes a monthly newsletter for the public. Additionally, the center offers specialized education programs on ABP manufacturing, quality control, product approval, and related regulations for industry professionals.

Conclusions: The Regulatory Science Center will continue its efforts to ensure the safety and protect the health of patients by monitoring the full cycle of ABPs and developing and maintaining a stable safety management system.