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

At the opening ceremony, KPBMA Vice Chairman Lee Che-guk described the event as “an important opportunity to advance the pharmaceutical industries of both countries and deepen our cooperative relationship,” and reflected on the progress made since the first symposium in 2003.Kenshi Kinoshita, Chairman of the JPMA, emphasized that this was “a valuable opportunity to share insights and seek solutions to the common challenges facing both countries.”

Mr. Kim Sang-bon, Director General of the Bureau of Drug Safety at the Ministry of Food and Drug Safety (MFDS) of South Korea, highlighted the significance of the 10th anniversary of the signing of the Memorandum of Understanding (MOU) on regulatory cooperation between Japan and South Korea, and Mr. Yasuhiro Fujiwara, Chairman of the Pharmaceuticals and Medical Devices Agency (PMDA)(PMDA Chief Executive), stated, “Ensuring the ecosystem functions effectively, through collaboration among regulatory authorities, industry, and academia, is essential for the development of innovative pharmaceuticals and improving patient access.”

In the session on the clinical development environment, JPMA Drug Evaluation Committee member Ayako Okayasu introduced the challenges of clinical development in Japan and efforts to improve efficiency, while KPBMA's Lee Seong-Oh explained measures to accelerate clinical development using digital technology, such as 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. JPMA International Affairs Committee member Shinya Mamiya and KPBMA's Jin-hee Kim presented issues 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 the conditional benefit system for innovative drugs, stating that Korea is seeking a balance between appropriate compensation for R&D companies in spite of 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, JPMA member, 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 status of R&D investment in the Korean pharmaceutical industry and the problem of evaluation of 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, Mr. Lee Jae-guk, Vice Chairman of the KPBMA, stated that “creating a predictable environment is the key to industrial development” and announced that the next, 7th symposium would be held in South Korea.Nobuo Murakami, Chairperson of the JPMA’s International Affairs Committee, emphasized, “Given limited financial resources, it is important to continue joint public-private and Japan-Korea efforts to address the difficult challenge of balancing the evaluation of innovative pharmaceuticals with cost-effectiveness.”Mr. Daisaku Sato, Deputy Director-General of the Minister’s Secretariat at the Ministry of Health, Labor and Welfare, commented, “It was extremely meaningful to have a frank exchange of views on the common challenges facing both Japan and South Korea.”

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