Topics “The 9th Japan-Taiwan Pharmaceutical Exchange Conference” Held
On October 14, 2021, the “9th Japan-Taiwan Pharmaceutical Exchange Conference” was held. Although the event was originally scheduled to take place in Taiwan, due to the COVID-19 pandemic, as was the case in 2020, attendees from both the Japanese and Taiwanese sides—excluding presenters and secretariat staff—participated online.
Scenes from the Online Conference
This exchange conference originated from the “Agreement between the Japan-Taiwan Exchange Association (Japan side) and the Asia-East Relations Association (now the Taiwan-Japan Relations Association,the Taiwan side) for the Establishment of a Framework for Cooperation on Pharmaceutical Regulation (commonly referred to as the “Japan-Taiwan Pharmaceutical Regulatory Cooperation Agreement”)” on November 5, 2013. This led to the holding of the “1st Japan-Taiwan Pharmaceutical Exchange Conference” in Taipei in December 2013.The main provisions of the “Japan-Taiwan Pharmaceutical Regulatory Cooperation Agreement” include establishing a platform for mutual understanding and cooperation regarding pharmaceutical regulations between Japan and Taiwan, as well as making requests for cooperation to the regulatory authorities of both sides.Against this backdrop, while laying the groundwork for a cooperative framework between the two sides, each conference features increasingly in-depth presentations and discussions on various topics, and a collaborative review scheme for new drugs is also underway.At this exchange conference, more than 800 participants from the pharmaceutical and medical device sectors in Japan and Taiwan attended. They shared the latest information on regulatory frameworks for orphan drugs and health insurance systems related to the novel coronavirus disease (COVID-19),pharmaceutical regulations for orphan drugs, and health insurance systems. By discussing mutual challenges, the event fostered a deeper mutual understanding aimed at creating innovative new drugs tailored to the aging societies of Asia.
On the Japanese side, the event was organized by the Japan-Taiwan Exchange Association and sponsored by the Pharmaceuticals and Medical Devices Agency (PMDA) and the JPMA.Numerous representatives from relevant organizations participated, including Mr. Naoyuki Yasuda, Director of the International Pharmaceutical Regulatory Affairs Office, General Affairs Division, Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare; Mr. Shinobu Utsu, Executive Director of the PMDA; Ms. Sachiko Nakagawa, Executive Director of the JPMA; and representatives from the Japan Medical Device Industry Federation (JMDIF).
On the Taiwanese side, the event was organized by the Taiwan-Japan Relations Association and attended by Ms. Wu Hsiu-mei, Director-General of the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare, as well as representatives from the Center for Drug Evaluation (CDE), the Central Health Insurance Administration (NHIA) under the Ministry of Health and Welfare,the Pharmaceuticals and Medical Devices Committee of the Taipei Japan Chamber of Commerce and Industry (JCCI PMDC), the Taiwan Pharmaceutical Manufacturers Association (TPMA), the Taiwan Research and Development-Oriented Biotechnology and New Drug Development Association (TRPMA), the Republic of China Innovative Pharmaceutical Research Association (IRPMA),Taiwan Generic Pharmaceutical 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).
To begin the event, opening remarks and congratulatory addresses were delivered by Mr. Hanaki, Executive Director of the Japan-Taiwan Exchange Association, andMr. Lin Qinghong, Deputy Secretary-General of the Taiwan-Japan Relations Association, expressed their expectations for this conference—which continues to be held even amid the global COVID-19 pandemic—namely, to promote the harmonization of pharmaceutical regulations between the two sides and to deepen mutual understanding regarding healthcare insurance systems.In addition, Mr. Hanaki once again expressed his gratitude for the support provided during the 2011 Great East Japan Earthquake, while Mr. Lin expressed his gratitude for the supply of 3.9 million doses of the COVID-19 vaccine from Japan to Taiwan.
At this 9th exchange meeting, as in the previous session, discussions focused on pharmaceuticals and medical devices.First, as a joint keynote session on pharmaceuticals and medical devices, both authorities provided updates on regulatory information. This was followed by a sharing of Taiwan’s and Japan’s respective initiatives regarding various responses to COVID-19, an introduction to pharmaceutical regulations concerning orphan drugs, and a discussion on health insurance.
1. Keynote Speech
Regarding updates on regulations for pharmaceuticals and medical devices, the Taiwanese side presented the latest status from the TFDA, while the Japanese side presented the latest status from the PMDA.
The TFDA presented on Emergency Use Authorization (EUA) for COVID-19 vaccines, evaluation methods for domestically produced vaccines (the “immune bridging” method), and the latest trends regarding clinical trials and medical devices.They shared their intention to promote the digitization of Common Technical Documents (CTD) and e-labeling; noted that new regulations for medical devices (the Medical Devices Management Act) have been in effect since May 1, 2021; and announced the issuance of guidelines regarding AI-enabled smart medical devices.Furthermore, regarding the collaborative new drug review scheme with Japan that began in 2019, it was noted that three cases have been completed to date, with two currently under review, and that this scheme has proven beneficial for both parties. Finally, the speaker expressed gratitude to Japan for the valuable experience gained through the collaboration to date and stated a desire to continue actively pursuing cooperation in the future.
The PMDA presented on: (1) the latest initiatives regarding the development of COVID-19 vaccines; (2) e-labeling for package inserts; (3) trends in regulatory science, approaches to clinical trials in Asia, and the utilization of real-world data (RWD).Finally, it was noted that the 9th Exchange Meeting was successfully held despite the COVID-19 pandemic, and that both parties hope to continue sharing the latest information and collaborating for the mutual benefit of Japan and Taiwan, as well as for the development of Asian countries.
2. Initiatives Related to COVID-19
In this session, the current status of efforts regarding COVID-19 was presented.
Representatives from Taiwan highlighted that the number of COVID-19 cases has been kept lower compared to other countries and presented initiatives regarding clinical trials during the COVID-19 pandemic, including patient registration, telemedicine, the provision of investigational drugs, and monitoring, audits, and inspections.It was noted that, for the development of a COVID-19 vaccine, a subject registration platform was established, and over 20,000 people registered in just one month, demonstrating an excellent initiative that utilized IT to achieve rapid and appropriate results.
Representatives from Japan provided an overview of the COVID-19 situation and the efforts of the pharmaceutical regulatory authorities. They noted that, due to factors such as the progress of the vaccination campaign, the number of COVID-19 cases in Japan has recently fallen below 1,000, and they also discussed Japan’s special approval system for the rapid introduction of vaccines and therapeutics.
Furthermore, the following were identified as future global challenges: (1) the development of next-generation vaccines through comparative trials with existing vaccines, (2) booster shots, and (3) exploring ways to expand production capacity.Furthermore, the initiatives of the International Coalition of Medicines Regulatory Authorities (ICMRA)—a forum for international pharmaceutical regulatory authorities—were shared, and it was noted that international collaboration will become increasingly important not only in addressing the current pandemic but also in preparing for future pandemics and shaping the “New Normal.”
3. Regulations on Orphan Drugs
In this session, both authorities presented their regulations regarding orphan drugs.
Representatives from Taiwan provided explanations regarding (1) the regulatory environment for orphan drugs, (2) the review process for orphan drugs, and (3) post-approval requirements.Detailed information was provided regarding regulations for orphan drugs in Taiwan, including the criteria for rare disease designation—defined as affecting no more than one in 10,000 people—incentives upon designation, the review process (Rare Disease Designation → Orphan Drug Designation → Application for Approval),and the requirement to submit annual reports pursuant to Article 21 of the “Rare Diseases and Orphan Drugs Act.”
A presentation was given on Japan’s designation system for orphan drugs and other treatments, which began in 1993. The eligibility criteria for this system are: (1) the condition must affect fewer than 50,000 patients in Japan or be designated as an intractable disease;(2) the disease must be severe and have a high medical need; and (3) the development must be highly feasible and justified. It was also noted that incentives for developing companies include grants, tax measures, priority consultation, priority review, drug price markups, and extensions of the re-evaluation period.It was also noted that drugs for rare diseases undergo priority review, with the process from disease designation to approval taking approximately nine months—about three months shorter than the standard review process.
4. Health Insurance Systems
During this session, both authorities provided an overview of their drug pricing systems.
Taiwan shared the current status of its health insurance and drug pricing systems. First, in addition to a single-payer system, Taiwan has introduced a Global Budget system, which operates within a fixed annual total healthcare expenditure limit;Furthermore, regarding the pricing rules for new drugs, they explained that there is a system that references prices in 10 advanced countries (10 designated countries), and they provided an overview of actual review periods, Managed Entry Agreements (MEAs), and Horizon Scanning. They also noted that, given the limited resources of the health insurance system, expectations for precision medicine are rising.Finally, the NHIA stated that its policy is to pay for effective drugs and allocate resources where they are needed, and that it aims to collaborate with the industry to provide patients and the people of Taiwan with high-quality, cost-effective medications.
Representatives from Japan provided an overview of Japan’s drug pricing system, reimbursement rules, and cost-effectiveness evaluation system.Regarding pricing rules for new drugs, a wide range of rules were shared, including the comparative pricing method (when comparable drugs exist), the cost-based pricing method (when no comparable drugs exist), special surcharges applied when utility and novelty are recognized, and adjustments based on overseas drug prices.Regarding the cost-effectiveness evaluation system, while Taiwan conducts such evaluations prior to drug price listing, Japan uses them after listing to adjust drug prices. When asked by the Taiwanese side about the reason for this difference, the Japanese side explained that cost-effectiveness evaluations take time, and this approach is intended to ensure that new drugs reach patients as quickly as possible.
5. Summary
This exchange meeting, which began in 2013, marked its ninth iteration. Working groups on pharmaceuticals and medical devices have been established between the two authorities, and personnel exchanges and collaborative schemes for new drug review are progressing.As was the case in 2020, the meeting could not be held in person due to COVID-19; however, we were still able to engage in lively discussions, and regarding pharmaceutical regulations, I gained an understanding of how both authorities are incorporating innovation and other factors into their regulatory frameworks.Furthermore, regarding the COVID-19 situation and related initiatives, both sides highlighted how they are implementing measures flexibly and swiftly. I felt it is essential for both authorities to maintain continuous communication and deepen mutual understanding and trust moving forward.The 10th meeting, a milestone event, is scheduled to be held in Japan in 2022. We sincerely hope that the 2022 meeting will take place in person, and we earnestly hope that, under this framework, regulatory cooperation and mutual understanding regarding pharmaceuticals and medical devices in Japan and Taiwan will continue to be promoted by both the public and private sectors.
(International Affairs Committee, Asia Subcommittee, Taiwan Team: Tatsuya Koyama, Shingo Ikegami, Osamu Kagawa )