- Date2025-11-18
HIRA Successfully Concludes 2025 International Symposium
– Discussing Directions for Improving the Approval System for Off-Label Use of Drugs and Medical Devices –
The Health Insurance Review and Assessment Service (HIRA, President Kang Joong-gu) successfully held the 2025 HIRA International Symposium on August 29 (Friday) at The Westin Chosun Seoul, under the theme “Current Status and Future Directions of the Approval System for Off-Label Use of Drugs and Medical Devices.”
More than 300 participants, including speakers from five countries (such as the United States and the United Kingdom), domestic and international healthcare experts, and members of the public, took part in the symposium.
Active discussions were held on the future direction of the off-label use approval system, with participants sharing diverse perspectives and insights.
congratulatory messages from National Assembly Health and Welfare Committee Chair Park Joo-min and Second Vice Minister of Health and Welfare Lee Hyung-hoon
In the keynote session, Professor David A. Simon of Northeastern University School of Law (U.S.) presented on the international outlook of off-label use approval systems.
Following that, Commissioner Seo Dong-cheol of HIRA introduced the current status and future direction of Korea’s system.
The first session featured Mr. Andrzei Orlowski, Head of the UK National Health Service (NHS), who explained the regulatory framework and practical cases of off-label use for medical devices in the UK, emphasizing the importance of national guidelines.
Professor Andrea Parziale from Sant’Anna School of Advanced Studies (Italy) presented on Europe’s regulatory scope and management systems for off-label use of medical devices.
The session concluded with Dr. Jang Yang-soo, Chair of the Medical Evaluation Committee at HIRA, who presented on the challenges and improvement measures for Korea’s off-label medical device approval system.
In the second session, Professor Hisashi Urushihara from Keio University (Japan) discussed Japan’s off-label drug approval system, focusing on its regulatory challenges and analyzing the differences between Korea’s and Japan’s approaches.
Mr. Wei-I Huang, Head of the Taiwan National ADR Reporting Center, presented on Taiwan’s regulations and risk management measures for off-label drug use.
Finally, Professor Lee Jae-ryeon of Asan Medical Center (Korea) emphasized the importance of the off-label drug approval system in terms of expanding treatment opportunities for patients.
After each session, a panel discussion was held, chaired by Dr. Jang Yang-soo, Chair of the Medical Evaluation Committee, and Dr. Lee Jung-shin, Chair of the Drug Reimbursement Evaluation Committee. Experts from various sectors — including the Ministry of Health and Welfare, the Ministry of Food and Drug Safety, and the medical community — participated in in-depth discussions on practical and rational directions for improving the system.
HIRA President Kang Joong-gu stated,
“The approval system for off-label use of drugs and medical devices is a crucial topic that must balance the diverse treatment needs of clinical settings with safety and efficiency considerations.
Today’s symposium served as a meaningful forum for gathering the experience and wisdom of international experts, and I hope it will contribute to further advancement of the system.”
