Topics Held the "5th Japan-Korea Symposium on Medical Product Regulations

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On September 4, 2023, the "5th Japan-Korea Symposium on Medical Product Regulation" was held in Seoul (Korea). This symposium began in 2004 and has been hosted by the private sector for the purpose of mutual understanding of the environment surrounding the pharmaceutical industry in Japan and Korea, and has been jointly hosted by the public and private sectors since 2016. Due to the impact of the new coronavirus infection (COVID-19) and other factors, the symposium was suspended after 2020, but will now be held under industry sponsorship for the first time in four years, since 2019. Many people from authorities and industries in Japan and Korea participated in the symposium, with 139 people attending on-site.

The Japanese side was organized by the Pharmaceutical Manufacturers Association of Japan (PMAJ) and supported by the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA). Many people from related organizations attended, including Daisuke Koga, Director of the Office of International Pharmaceutical Regulations, General Affairs Division, Pharmaceutical Affairs Bureau, MHLW, and Hiroyoshi Arai, Director of PMDA. From the Pharmaceutical Manufacturers Association of Japan, Executive Director Sachiko Nakagawa (center photo) and Team Leader Tatsuya Koyama, Sub-team Leader Hisanori Mizuhara, and Sub-team Leader Taeho Kim of the Korea Team of the International Committee's Asia Subcommittee participated and expressed their opinions.

The Korean side was hosted by the Korea Pharmaceutical Products Manufacturers Association (KPBMA) and supported by the Korea Ministry of Food and Drug Safety (MFDS).

The symposium, the fifth of its kind, featured a Keynote Speech by the two authorities updating regulatory information, followed by a presentation on regulatory review reliance, Real World Data (RWD)/Real World Evidence (RWE), and the supply of Active Pharmaceutical Ingredients (APIs). There was also a discussion on medical insurance.

Keynote Speech

Regulatory updates on pharmaceutical products were presented by both Korea and Japan.

MFDS introduced various measures taken for COVID-19, such as approval for use in special cases, establishment of an expedited review system, and production orders for therapeutic drugs, as well as the introduction of e-labeling, and introduced 27 products from 10 companies that were subject to a pilot program. In addition, he mentioned that he would like to promote the gradual expansion of e-labeling, starting with injectable drugs that are directly administered at medical institutions among specialty drugs.

In addition, he mentioned that it has become difficult to maintain the same clinical trial system as before due to the decrease in face-to-face consultations caused by COVID-19, and that he is promoting decentralized clinical trials (DCT) utilizing digital technology by using Korean domestic technological capabilities, as demand for digital technology has increased.

Since the domestic distribution of certain drugs was disrupted due to shortages of certain drugs and unexpected external factors for items with high import dependency during the COVID-19 epidemic, they are considering measures such as inducing decentralized prescribing, optimizing drug prices, and equal distribution whenever there are shortages, and that they are going to promote designation of national essential drugs and establishment of production systems to secure such drugs in the future. The PMDA also mentioned that it will continue to promote the designation of national essential drugs and the establishment of a production system to ensure the designation of such drugs.

PMDA introduced PMDA's response to the development of overseas ventures in Japan in light of recent drug development. The PMDA is responsible for creating a better environment for the creation of new drugs. Specifically, the PMDA is considering establishing an early-stage development consultation service to pave the way for new drug development, as well as to publicize the benefits of the priority review system. Asia is a region with a growing population, and it is assumed that the pharmaceutical market in Asia will become more active in the future. In order to facilitate drug development, the issue is how to discuss the evaluation system for drugs in the Asian region as a whole. He also introduced that PMDA has established overseas offices in Asia and the U.S. to collect information and provide development support.

Regulatory review reliance

The MFDS has been working for the international harmonization of GMP and for the accession to the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Cooperative Scheme (PIC/s) in order to make the pharmaceutical industry an export-oriented industry. Based on this history, they are promoting bilateral agreements such as the GMP Mutual Confidence Agreement with Switzerland and GMP Mutual Recognition Agreement with Singapore. He said that he would like to expand the scope of bilateral agreements to include the United States, Europe, Japan, and other countries in the future.

Regarding GMP support in the Association of Southeast Asian Nations (ASEAN), PMDA is conducting activities such as GMP conferences and GMP inspector education to deepen mutual understanding.

The PMDA also mentioned that the number of seeds originating from academia has been increasing in recent years, and that the PMDA is supporting the improvement of access to pharmaceuticals and medical devices by providing advice on roadmaps, consultation on clinical trials, and consultation on regenerative medicine products through the Regulatory Science Consultation. PMDA is also supporting the improvement of access to medicines and medical devices through Regulatory Science Consultation.

The environment surrounding pharmaceuticals has changed significantly after the COVID-19 pandemic, and MRCTs are expected to continue to increase, making it important to utilize Reliance. PMDA is conducting activities through the Asia Training Center to strengthen the capacity of Asian regulatory authorities.

RWD/RWE 4.

In this session, the current status of RWD/RWE activities was introduced.

As an example of RWD utilization, he introduced the case of Kim Rhea, which is utilized in research design, evaluation indices, statistical analysis methods, selection of research subjects, and comparative analysis of clinical characteristics, and discussed the appropriate use of RWD and RWE. To evaluate the appropriateness of RWD, he also presented the regulatory concordance and estimated concordance between the results of the survival analysis and the EMA's decision-making. He mentioned that the key issues for future dissemination include securing a usable registry, minimizing missing values, and QC of the registry.

The MHLW stated that although randomized controlled trials are the golden standard for clinical trials, it is difficult to conduct comparative trials for intractable and rare diseases, for which the number of eligible patients is limited. The Ministry of Health, Labour and Welfare is promoting the use of the registry by establishing a consultation system for its use. The guideline for the use of the registry in applications for approval classifies examples of registry use into five categories, organizes basic ideas and points to keep in mind, and divides points to keep in mind to enhance the reliability of the registry into "the status of the registry holder that the applicant should confirm" and "matters to be addressed by the applicant, etc." The guideline also provides that the level of reliability required by the intended use of the registry should be determined by the intended use of the registry, He also mentioned that since the required level of reliability differs depending on the purpose of use, it is recommended to consult with the PMDA.

Sustainable Supply Chain to Avoid API shortage 5.

In this session, the current situation regarding the stable supply of APIs was introduced.

The Korean side shared that exports of active pharmaceutical ingredients to Japan have been increasing, but the situation is changing due to problems in 2019-2022 (Corona Disaster), and that the JDMF (Japanese Drug Master File) registration (items and companies) by country is decreasing in Korea and Japan, while China and India are increasing. The issues surrounding generics in Japan are still being addressed by the Japanese government. The presentation also touched on issues surrounding generic drugs in Japan, such as inadequate quality control, supply uncertainty, and low profitability, and expressed the desire to promote entry into Japan as a measure for export business of Korean API.

From Japan, the activities of the Japan Pharmaceutical Traders Association and the status of generics in Japan were introduced. The association is working to promote quality testing and inspections of imported APIs, to inform the public about the Japanese pharmaceutical affairs system and to cooperate with related domestic and foreign organizations in order to promote a stable supply of imported APIs, etc. About 60% of Japan's APIs for generic drugs are imported, and the supply chain is highly dependent on China and India, but there is a sense of trust regarding quality and compliance, and the association is able to communicate easily with the public. In addition, Korea is one of the most important suppliers of APIs to Japan in terms of quality and compliance, ease of communication, and so on.

Health Insurance for Sustainable Universal Health Coverage

In this session, both authorities introduced the NHI drug price system, followed by a panel discussion including the industry.

The Ministry of Health and Welfare (MoHW) of the Republic of Korea (ROK) spoke about how the government aims to create a balanced policy so that companies that focus on research and development can be adequately covered by NHI prices, given the financial problems of health insurance due to the declining birthrate and aging population. Korea's universal health insurance system is similar to Japan's, but is characterized by a single payer system under the National Health Insurance System (NHIS).

In addition, he reported that Korea's total medical expenses are approximately 98 trillion won, of which 22.9 trillion won is spent on pharmaceuticals, and the ratio is decreasing from 24.1% to 23.3% by 2022. Regarding the Health Technology Assessment (HTA), he mentioned that the Incremental Cost Effectiveness Ratio (ICER) value is used fluidly and no fixed value is adopted, and that RSA (risksharing agreements), which is not available in Japan, mainly covers basic anticancer drugs and drugs for rare diseases, while other drugs are selected by the relevant committee. Other drugs are selected by the relevant committee. As for the improvement of the NHI drug price system, the MHLW is considering the expansion of the scope of innovation and the calculation of higher NHI drug prices, as well as the guarantee of essential drugs at reasonable prices.

The Ministry of Health, Labour and Welfare (MHLW) also stated that the unstable supply of pharmaceuticals has become a problem and that various measures as well as drug pricing policies are under consideration, and that, as in South Korea, there is a problem of insurance financing due to the declining birthrate and aging population, but the pharmaceutical industry is an important industry in Japan's economic growth and is also important from the perspective of security, and that it is important to always consider appropriate coverage for innovative drugs. He also stated that the pharmaceutical industry is an important industry in terms of Japan's economic growth and security, and that he is always thinking about appropriate coverage for innovative pharmaceuticals.

He also stated that it is necessary to make transparency and predictability clearer, and to work with the public and private sectors to make the pharmaceutical market more attractive in order to attract investment and improve access to healthcare for patients.

Panel Discussion

At the beginning of the session, the Korean and Japanese industries commented on the healthcare insurance system.

The Korean industry commented that the Korean government has established an "innovative pharmaceutical company certification system" and offers preferential treatment to companies with high R&D investment rates, and that although the R&D investment rates of the top few companies have increased year by year, they are still small compared to global companies, and that there are still many companies with poor R&D. There are many companies that still lack R&D, and the committee also commented that they would like to see the NHI price preferential treatment reflect the R&D investment rate of each company.

The Japanese industry reported that the attractiveness of the Japanese pharmaceutical market has decreased and the number of products not launched in Japan has increased year by year, with only about half as many products being launched in Japan as in the U.S. (a drug lag/loss problem, so to speak). The panelists commented that while it is important to maintain insurance financing, the problem of necessary drugs not reaching patients should also be seriously addressed.

During the panel discussion, the MHLW commented on the drug lag/loss issue and the need to establish a policy to balance and balance insurance finances while recognizing highly innovative drugs. The MoHW also mentioned that, since there had been no innovative new drugs up to now, it would be difficult to provide the same additional benefits as in Japan, but that efforts were being made to create policies that would guarantee innovative new drugs while considering the order of priority. From the industry side, many Korean pharmaceutical companies are still concentrating on best-in-class new drugs, but if there is a system to compensate sunk costs of companies, many companies will shift from generic-centered entities to new drug development. The Japanese industry commented on the importance of efforts to manage medical waste and the need to develop a system to enable One Patient One Record management.

Summary

The fact that this symposium was held face-to-face, the first time it has resumed since 2019, made it a very meaningful symposium where the latest information was shared from both Japan and Korea on a wide range of topics, as well as lively discussions and exchanges of opinions. The mission of pharmaceutical companies is to provide patients with high quality evidence of efficacy and safety, as well as innovative drugs of high quality, as quickly as possible. In order to improve the drug lag/loss problem that has become an issue in Japan and Korea, I felt that it is essential for the pharmaceutical authorities and industries in Japan and Korea to continue communication in various areas such as digital, innovation, and regulatory harmonization, and to deepen mutual understanding and trust between the two countries. We hope that the resumption of the Japan-Korea Symposium will be an opportunity for the public and private sectors to make progress in regulatory harmonization, cooperation, and mutual understanding of regulatory systems for pharmaceuticals and medical devices in Japan and Korea.

( Tatsuya Koyama, Taeho Kim, and Toshinori Mizuhara, Korea Team, Asia Subcommittee, International Committee)

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