The 6th Japan-Korea Symposium on Pharmaceutical Regulation was held. Pharmaceutical regulatory authorities and industries from Japan and Korea gathered to discuss common issues

At the opening ceremony, KPBMA Vice President Lee Chae-guk noted that the symposium was "an important opportunity for the development of the pharmaceutical industries in both countries and for the deepening of cooperative relations," and reviewed the development of the symposium since the first symposium in 2003. KPBMA President Kenshi Kinoshita stressed that the symposium was "a valuable opportunity to share knowledge and seek solutions to common challenges facing both countries.

Mr. Kim Sang-Bong, Director General of the Drug Safety Bureau of the Korean regulatory authority (MFDS), emphasized the significance of the 10th anniversary of the signing of the MOU on regulatory cooperation between Japan and Korea, and Mr. Yasuhiro Fujiwara, President of the Pharmaceuticals and Medical Devices Agency (PMDA), commented that "the effective functioning of the ecosystem, together with collaboration between authorities, industry, and academia, will lead to the development of innovative drugs. The effective functioning of the ecosystem, together with the cooperation of the regulatory authorities, industry, and academia, is essential for the development of innovative drugs and improved patient access to them.

In the session on the clinical development environment, Ayako Okayasu, a member of the Pharmaceuticals Evaluation Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), introduced the challenges of clinical development in Japan and efforts to improve efficiency, while Lee Seong Oh of the KPBMA explained measures to accelerate clinical development using digital technologies, including AI-based protocol design and distributed clinical trials.

Hideaki Kuribayashi of PMDA and Myeong Ahn of MFDS reported on their respective measures to promote global clinical trials. Mr. Okayasu commented that, in consideration of the development of personalized medicine, there is currently limited information on clinical trials accessible to patients. He commented that "Currently, patients have limited access to clinical trial information, and it is necessary to establish a system that allows patients to access clinical trial information more easily and to find clinical trials on their own. In the RWD/RWE session, Masaaki Urata of PMDA explained the use of Japanese registries in regulatory applications and related guidelines, and Myung-Hoon Chung of MFDS introduced a Korean case study of approval using medical big data.

In the session on Market Access Patient Access Improvement Strategy, Dr. Kuhi Kim of HIRA explained the Korean health insurance system and drug benefit system, and Mr. Kaita Fujiwara of MHLW introduced Japan's NHI drug price calculation system and innovative drug evaluation system. Shinya Mamiya, a member of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), and Jin-hee Kim, a member of the KPBMA, presented their challenges and recommendations from their respective industry perspectives.

Ms. Koohee Kim of the Korea Health Insurance Review and Assessment Agency (HIRA) explained Korea's single insurer system and conditional benefit system for innovative drugs, and stated that Korea is seeking a balance between appropriate compensation for R&D companies despite the declining birthrate and aging population. Kaita Fujiwara, MHLW, introduced the innovative addition system in Japan's drug pricing system, citing the case of Sovaldi's 70% addition and explaining measures such as re-calculation of unprofitable products to ensure a stable supply. Mr. Shinya Mamiya, a member of the Pharmaceutical Manufacturers Association of Japan (PMAJ), emphasized the contribution of the pharmaceutical industry to the economy, but also expressed concern that continuous drug cost reductions will worsen the investment environment, and stressed the importance of cross-agency dialogue, continuous discussion between the public and private sectors, and improved predictability. Mr. Kim Jin-yi of the KPBMA pointed out the R&D investment situation in the Korean pharmaceutical industry and the problem of evaluating domestically developed new drugs, and proposed the establishment of a global supply chain through cooperation between Japan and Korea. In the panel discussion, the importance of a transparent evaluation process and a well-structured drug pricing policy were confirmed in order to build a win-win-win relationship among patients, authorities, and the industry.

In the session on NHI drug price system and industrial development policy, Dr. Jung-Hoon Ahn of Ewha Womans University presented issues and suggestions for improvement of the Korean NHI drug price ex-post control system, and Mr. Kaita Fujiwara of the Ministry of Health, Labor and Welfare explained the balance between the NHI drug price system and industrial policy in Japan.

During the Q&A session, the introduction of the R-Zone, which is under consideration in Korea, and responses to the drug lag/loss problem in both countries were also discussed.

At the closing ceremony, KPBMA Vice President Lee Jae-guk stated that "a predictable environment is the key to industrial development" and announced that the next 7th Symposium would be held in Korea. Nobuo Murakami, Chairman of the International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ), stressed the importance of continuing joint efforts by the public and private sectors in Japan and Korea to address the difficult issue of how to balance the evaluation of innovative drugs and economic efficiency within the limited financial resources available. Daisaku Sato, Deputy Director General of the Minister's Secretariat of the Ministry of Health, Labour and Welfare, praised the symposium, saying, "It was very meaningful to have a frank exchange of views on the common issues facing both Japan and Korea.

After the symposium, a networking reception was held to deepen exchanges among the participants.