Topics The 9th Japan-Taiwan Pharmaceutical Exchange Conference" was held.
The "9th Taiwan-Japan Pharmaceutical Exchange Conference" was held on October 14, 2021. Although the conference was originally scheduled to be held in Taiwan, due to the Corona disaster, both Japanese and Taiwanese audiences except for presenters and the secretariat participated online, as they did in 2020.
A scene from the online conference
This exchange conference was held as a result of the November 5, 2013 signing between Japan and Taiwan of the "Arrangement between the Japan-Taiwan Exchange Association (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" (abbreviated as "Japan-Taiwan Pharmaceutical Regulatory Cooperation Arrangement"), The "First Japan-Taiwan Pharmaceutical Exchange Conference" was held in Taipei in December 2013. The main contents of the "Japan-Taiwan Regulatory Cooperation Arrangement" are to establish a platform for mutual understanding and cooperation in regulatory affairs between Japan and Taiwan, and to request cooperation from the regulatory authorities of Japan and Taiwan. Against this background, in addition to the formation of a foundation for cooperation between the two sides, more in-depth presentations and discussions are held on each topic, and a cooperative scheme for the review of new drugs is underway. The conference will be attended by more than 800 participants from the pharmaceutical and medical device industries in Japan and Taiwan, who will share the latest information on measures against new coronavirus infection (COVID-19), pharmaceutical regulations and health insurance systems for rare disease drugs, and discuss issues of both sides, in order to promote the development of innovative and innovative drugs for an aging society in Asia. The Japanese side was hosted by the Japan-Taiwan Exchange Association, and the Japanese side was hosted by the Japan-Taiwan Society for Cultural Exchange.
The Japanese side was hosted by the Japan-Taiwan Exchange Association and supported by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Pharmaceutical Manufacturers Association of Japan (PMAJ). Many people from related organizations attended, including Mr. Naoyuki Yasuda, Director of the Office of International Pharmaceutical Regulations, General Affairs Division, Pharmaceuticals and Consumer Health Bureau, Ministry of Health, Labour and Welfare, Mr. Shinobu Utsu, Director of PMDA, and other Japanese regulatory authorities, as well as the Pharmaceutical Manufacturers Association of Japan (PMAJ), including Executive Director Shoko Nakagawa, and the Japan Federation of Medical Devices Industry (JFMDA).
On the Taiwan side、 The Japan Relations Association of Taiwan sponsored the event.、 Food and Drug Administration, Ministry of Health and Welfare（TFDA） Director of the Food and Drug Administration, Ministry of Health and Welfare, Mr. Wu Shu-mei、 Center for Pharmaceutical Inspection and Testing（CDE）、 Central Health Office, Ministry of Health and Welfare（NHIA）、 Taipei Japanese Chamber of Commerce and Industry Pharmaceutical and Medical Device Division（JCCI PMDC）、 Taiwan Pharmaceutical Manufacturers Association（ Taiwan Pharmaceutical Manufacturers Association (TPMA), Taiwan Research-based Pharmaceutical Research and Development Association (TRPMA), Taiwan Research and Development of Pharmaceuticals (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). The event was held under the sponsorship of the CPMDA, TMBIA, and TFMDCA.
In their opening remarks, Mr. Izuru Hanaki, Executive Director of the Japan-Taiwan Friendship Association, and Mr. Ching-Hong Lin, Deputy Secretary General of the Taiwan-Japan Relations Association, expressed their expectations for the conference, which has been held continuously even under the global COVID-19 epidemic, namely to harmonize pharmaceutical regulations and to deepen mutual understanding of medical insurance systems in both countries. He also expressed his expectations for the conference, which continues to be held even under the global outbreak of COVID-19. Dr. Hanaki reiterated his gratitude for the support provided to Taiwan after the Great East Japan Earthquake in 2011, and Dr. Lin expressed his appreciation for the 3.9 million doses of new coronavirus vaccine supplied from Japan to Taiwan.
Continuing from the previous meeting, discussions on pharmaceuticals and medical devices were held at this 9th exchange meeting. After that, both Taiwanese and Japanese authorities shared their various efforts to respond to COVID-19, and the pharmaceutical regulations on orphan drugs were introduced. The discussion was then followed by the sharing of the efforts of both Taiwan and Japan to respond to COVID-19, the introduction of pharmaceutical regulations for orphan drugs, and a discussion on health insurance.
Keynote Speech
As regulatory updates on pharmaceuticals and medical devices, the TFDA from Taiwan and the PMDA from Japan presented the latest status.
The TFDA introduced the Emergency Use Authorization (EUA) for COVID-19 vaccine and the latest developments regarding the domestic vaccine evaluation method (Immune bridging method), clinical trials, and medical devices. It was shared that the government wants to promote digitization of Common Technical Documents (CTD) and e-labeling, that a new regulation (Medical Device Management Act) is operational as of May 1, 2021 regarding medical devices, and that guidelines on AI smart medical devices have been issued. Regarding the new drug review collaboration scheme with Japan that started in 2019, three cases have been completed so far and two cases are currently under review, indicating that this scheme is beneficial for both parties. He concluded by expressing his gratitude to Japan for the valuable experience gained through the past collaboration and his hope to continue to actively promote collaboration in the future.
PMDA introduced (1) the latest efforts in vaccine development for the new coronavirus, (2) e-labeling of the package insert, and (3) trends in regulatory science, the concept of clinical trials in Asia, and the use of real world data (RWD). In the end, he expressed his hope for continuous sharing of the latest information and continued collaboration between Japan and Taiwan for the mutual benefit of both countries and for the development of Asian countries.
Efforts regarding COVID-19
In this session, the current status of COVID-19 efforts was introduced.
Taiwan introduced their efforts in clinical trials under the COVID-19 epidemic, including patient registration, online medical care, provision of investigational drugs, monitoring and auditing/inspection, etc. To develop a COVID-19 vaccine, they established a subject registration platform and have been working on it for only one month. He introduced the situation in which more than 20,000 people were enrolled in just one month after the establishment of the subject registration platform for the development of COVID-19 vaccine, and how IT was used to implement prompt, appropriate, and excellent efforts.
From Japan, the status of COVID-19 and the efforts of the pharmaceutical regulatory authorities were introduced. He also introduced the special approval in Japan for the rapid introduction of vaccines and therapeutics.
In addition, as issues common to the world in the future, he mentioned (1) the development of next-generation vaccines through comparative studies with existing vaccines, (2) booster vaccination, and (3) consideration of expanding production capacity. In addition, the efforts of the International Coalition of Medicines Regulatory Authorities (ICMRA), a meeting body of international pharmaceutical regulatory authorities, were shared to discuss the need to prepare not only for the current pandemic, but also for future pandemics and to create a new New The session also discussed the increasing importance of international collaboration in preparing for not only current pandemics, but also future pandemics, and in creating a new New Normal.
Regulations on Orphan Drugs
In this session, both authorities introduced their regulations on Orphan Drugs.
Taiwan explained (1) the regulatory environment for orphan drugs, (2) the review process for orphan drugs, and (3) post-approval requirements. The criteria for rare disease designation in Taiwan is 1 in 10,000 or less, the incentives for being recognized, the review process (Rare Disease Designation => Orphan drug designation => Application for approval), and the "Rare Disease and Orphan Drug Review Process" (Rare Disease Designation => Orphan Drug Designation => Application for approval). The presentation also included a detailed explanation of the regulations regarding orphan drugs in Taiwan, such as the review process (Rare Disease Designation => Orphan Drug Designation => Application for Approval), and the requirement to submit an annual report in accordance with Article 21 of the Orphan Drugs and Orphan Drugs Act.
Japan introduced the Orphan Drug Designation System, which began in 1993. The requirements for designation under the orphan drug designation system are: (1) the number of patients in Japan is less than 50,000 or the disease is designated as intractable, (2) the disease is serious and there is a high medical need, and (3) the development potential is high and the drug is reasonable. The participants shared that incentives for development companies include subsidies, tax measures, priority consultation, priority review, additional NHI price, and extension of the reexamination period. It was also introduced that orphan drugs are subject to priority review, and that it takes about nine months from the designation of a disease to approval, which is about three months less than the normal review process.
Health insurance system
In this session, both authorities introduced the NHI drug price system.
Taiwan shared the current status of the insurance and drug pricing systems. First, in addition to the single-payer system, a global budget system has been introduced, and the system is operated within the context of a set total annual medical expenditure. He also introduced the actual situation of the review period, Managed Entry Agreement (MEA), and Horizon Scanning. He also shared that health insurance resources are limited and expectations for Precision Medicine are increasing. Finally, he indicated that NHIA has a policy of paying for effective drugs and using resources where needed, and that they would like to collaborate with industry to provide good and cost-effective drugs to patients and the Taiwanese public.
Japan introduced the NHI drug price system and calculation rules as well as the cost-effectiveness evaluation system. Regarding new drug calculation rules, a wide range of calculation rules were shared, including the comparable drug method (when there is a similar drug), the cost accounting method (when there is no similar drug), and special additions when usefulness or novelty is recognized, as well as overseas drug price adjustments. Regarding the cost-effectiveness evaluation system, Taiwan implements the system before the NHI drug price is listed, whereas Japan uses the system after the NHI drug price is listed and when adjusting the NHI drug price. The Taiwanese side was asked about the reason for this, and the Japanese side shared their view that the cost-effectiveness evaluation takes time and is used to deliver new drugs to patients as soon as possible.
General summary
This was the ninth exchange meeting since its inception in 2013, and both authorities have established working groups for pharmaceuticals and medical devices, and have made progress in personnel exchange and collaborative schemes for new drug review. In terms of regulations, we were able to understand how both authorities are incorporating innovations and other aspects into their regulations. The conference will be held in Japan in 2022, which will mark the 10th anniversary of COVID-19. I hope that the meeting will be held face-to-face in 2022, and that the public and private sectors will promote regulatory cooperation and understanding between Japan and Taiwan regarding pharmaceuticals and medical devices under the framework of this meeting.
( Tatsuya Koyama, Shingo Ikegami, Osamu Kagawa, Taiwan Team, Asia Subcommittee, International Committee)