The 12th Japan-Taiwan Pharmaceutical Exchange Conference held
December 19, 2024
The 12th Taiwan-Japan Pharmaceutical Exchange Conference was held on October 7, 2024 at the Nihonbashi Life Science Hub (Chuo-ku, Tokyo). This year, about 70 people from Taiwan's regulatory authorities and industries visited Japan, including the newly appointed Director of the Food and Drug Administration (TFDA), Ministry of Health, Labor and Welfare (MHLW), and the Independent Administrative Commission (IAC). From Japan, the Ministry of Health, Labor and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and industry attended with approximately 110 participants.
Group photo of the day by the organizers and sponsors
This is the 12th Taiwan-Japan Pharmaceutical Exchange Conference since the first one was held in Taipei in December 2013, based on the Arrangement between the Japan Foundation (Japanese side) and the Association for Relations with the Far East (now the Taiwan-Japan Relations Association, Taiwan side) for the Establishment of a Framework for Cooperation on Regulation of Medical Products, which was concluded on November 5, 2013 (abbreviated as "Japan-Taiwan Pharmaceutical Regulatory Cooperation Arrangement"). This is the 12th meeting since the first meeting was held in Taipei in December 2013 based on the "Japan-Taiwan Regulatory Cooperation Arrangement". The "Japan-Taiwan Regulatory Cooperation Arrangement" is intended to establish a platform for mutual understanding and cooperation on pharmaceutical regulations between Japan and Taiwan, and to request cooperation from the regulatory authorities of Japan and Taiwan. Against this backdrop, in-depth presentations and discussions have been held on various topics, while promoting the formation of a foundation for cooperation between the regulatory authorities and industries in Japan and Taiwan. In the area of new drugs, a cooperative new drug review scheme has been established and is being implemented to ensure that new drugs approved in Japan are launched efficiently and promptly in Taiwan.
The Japanese side was hosted by the Japan-Taiwan Exchange Association and supported by the PMDA, the Pharmaceutical Manufacturers Association of Japan, and others. Many people from various related organizations attended, including Daisuke Koga, Director of the Office of International Pharmaceutical Regulations, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare (MHLW), Emiko Kondo, Director of PMDA, and other Japanese regulatory authorities; Kenshi Kinoshita, President of the Pharmaceutical Manufacturers Association of Japan (PMAJ); and the Japan Federation of Medical Devices Industries and Associations (JFMDA). On behalf of the Pharmaceutical Manufacturers Association of Japan (PMAJ), Mr. Kenshi Kinoshita, President of PMAJ, gave the Opening Remarks.
The Taiwan side was hosted by the Taiwan-Japan Relations Association, and included the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare, the Center for Drug Evaluation (CDE), the Pharmaceutical and Medical Devices Division of the Taipei Municipal Industrial and Commercial Association (JCCI PMDC), the Taiwan Pharmaceutical Manufacturers Association (TPMA), the Taiwan Research-based Pharmaceutical Technology and New Drug Development Association (TRPMA), the Republic of China's Innovative Pharmaceutical Research and Development Association (IRPMA), Taiwan Generic Products Association (TGPA), Pharmaceutical Development Association of the Republic of China (CPMDA), Taiwan Medical Device Industry Association (TMBIA), and National Federation of Medical Device Trade Associations of the Republic of China (TFMDCA).
In this 12th exchange conference, keynote sessions were held by the two regulatory authorities to update information on pharmaceutical regulations, collaboration between Japan and Taiwan, and future prospects. This was followed by a discussion on the regulatory review of biosimilars and the medical insurance system, as well as the sharing of both Taiwanese and Japanese initiatives for early access and stable supply of innovative drugs.
Opening Remarks by Mr. Kenshi Kinoshita, Chairman of the
Pharmaceutical Manufacturers Association of Japan
Keynote Speech
As regulatory updates on pharmaceuticals and medical devices, the Taiwanese side presented the TFDA and the Japanese side presented the latest status of the PMDA.
PMDA introduced the 20th anniversary of PMDA's establishment, its growth as an organization, the number of employees exceeding 1,000, and the current status of drug lag/loss in Japan and measures to improve it (e.g., not requiring Japanese Ph1 before implementing the international joint Ph3). He also reported that PMDA has established offices in Thailand and Washington (US) to further deepen cooperation with the US and ASEAN countries.
TFDA shared the current status of biosimilars in Taiwan, recent regulatory updates and current status regarding regenerative medicine, clinical trials, and real world data (RWD)/real world evidence (RWE). The audience felt that Taiwanese companies are thinking about fostering domestic companies and industries, such as the approval of biosimilars by Taiwan in 2023. Taiwan is also very advanced in digital medical devices, with 45 (35.2%) of the 129 medical device programs (SaMD) approved to date having been developed by domestic companies. There was a sharing of the various exchanges of opinions and cooperation between Japan and Taiwan through the working groups for pharmaceuticals and medical devices, and the content of the meeting was promising for the development of pharmaceutical regulations in both countries in the future.
Improve patient access to innovative drugs and sustainable supply
In this session, initiatives on access to and stable supply of innovative drugs were introduced from Japan and Taiwan.
Makoto Ono, Vice Chairman of the GMP Subcommittee of the Pharmaceutical Manufacturers Association of Japan (PMAJ) Quality Committee, took the podium to introduce the challenges and industry initiatives to ensure early development, access, and stable supply of innovative drugs, which is the mission of the pharmaceutical industry. In order for Japan and Taiwan to continue to be selected as the countries to conduct clinical trials, it is necessary to take measures specific to each country and improve cost-effectiveness, and to promote registration of clinical trials by linking the clinical trial platform with electronic medical records and other means. He also mentioned ideas such as linking the clinical trial platform with electronic medical records to promote registration. He also mentioned the need for registration of a second manufacturing site to establish a stable supply system in case of emergencies such as new coronavirus infection (COVID-19).
TFDA made a presentation on its efforts to ensure stable supply and measures to prevent supply shortages. In recent years, shortages of supply of pharmaceuticals have become an issue. In Taiwan, the TFDA is taking a variety of approaches to address shortages, including demand forecasting, supply of APIs, manufacturing, and monitoring. He also mentioned that Taiwan is actively approaching the users of generic drugs by educating the general public about generic drugs (generic drugs are expected to have the same efficacy and safety as the original products).
Makoto Ono, Vice Chairman of GMP Subcommittee, Quality Committee of the Pharmaceutical Manufacturers Association of Japan (PAPJ), introducing their efforts for stable supply.
Biosimilar products regulations
PMDA shared that 36 biosimilars have been approved in Japan, and in recent years, applications and consultations for monoclonal antibodies and fusion proteins have been increasing, as well as the scientific approach to approval as shown in the guidelines and Q&A issued in Japan for ensuring quality, safety, and efficacy of biosimilars. The scientific approach to biosimilars in the review process was also shared. Biosimilars have a larger molecular weight and more complex structure than chemical products, and because they are produced through the protein synthesis pathway, their molecular structure is not necessarily identical to that of the predecessor product. In relation to the preliminary question, he introduced the background of the aforementioned Q&A revised in 2024, which states that the inclusion of Japanese nationals in clinical trials is not necessarily mandatory.
The TFDA introduced the points to be checked during pre-application consultation and review of biosimilars in Taiwan. He also explained the measures to promote the use of biosimilars, such as simplified pre-application review, relaxed restrictions, and cost incentives for prescribing biosimilars. I felt that they are actively working on the development of the domestic biotech industry.
Health insurance system
In this session, the Ministry of Health, Labour and Welfare (MHLW) and NHIA introduced the NHI drug pricing system and their current activities under the moderation of Mr. Tatsuya Koyama, leader of Taiwan Group, Asia Subcommittee, International Committee of the Pharmaceutical Manufacturers Association of Japan (PMAJ).
The MHLW introduced the situation of medical and drug costs in Japan, the NHI drug price system and calculation rules, and the details of this year's NHI drug price system reform. The new NHI drug price system is based on the two basic concepts of 1) evaluating innovation appropriately to eliminate drug lag/loss and 2) ensuring a stable supply of drugs, as well as the concept of recovering R&D investment costs during the patent period and handing over the role to generics after the patent expires. The concept is to recover R&D investment costs during the patent term and to hand over the role to generics after the patent expires.
The NHIA introduced the measures being taken in Taiwan to reduce the cancer mortality rate by one-third by 2030, including the promotion of screening tests, as well as the introduction of parallel review and the establishment of the Cancer Drugs Fund to speed up access to new drugs. He also introduced measures such as the introduction of parallel review and the establishment of the Cancer Drugs Fund to speed up access to new drugs.
The issues of drug lag and drug loss have been highlighted in recent years, and the government and private sector should work together to make the pharmaceutical market more attractive to attract investment and improve access to medical care for patients through greater transparency and predictability, and to maintain and develop universal health insurance in Japan and Taiwan. We believe that discussions involving the public are necessary in order to make the pharmaceutical market more attractive to the public, to attract investment, and to improve access to healthcare for patients.
Q&A session on health insurance system
Summary
This year marks the 12th time that this exchange conference, which began in 2013, has been held. In the course of our efforts to date, we have seen steady progress in harmonization and collaboration between the two authorities in new drug cases, including the review of the GCP inspection system in Taiwan in 2015, the addition of Japan to Taiwan's simplified review system in 2016, and the publication of a position paper on a collaborative scheme for new drug review between Japan and Taiwan in 2019. We feel that it is essential to continue to communicate through this exchange conference to deepen mutual understanding and trust between the regulatory authorities and industry.
The next conference is scheduled to be held in Taiwan in two years, in 2026. I hope that the public and private sectors will further develop their collaboration to date, promote regulatory harmonization and cooperation regarding pharmaceuticals and medical devices in Japan and Taiwan, and promote understanding of each other's regulatory systems, so that the public and private sectors can build a system to ensure that needed pharmaceuticals reach the patients who need them as quickly as possible.
(Tatsuya Koyama and Takae Harada, Taiwan Group, Asia Subcommittee, International Committee)