Topics The 8th Taiwan-Japan Pharmaceutical Exchange Conference held.
On October 15, 2020, the "8th Taiwan-Japan Pharmaceutical Exchange Conference" was held. Normally, the conference would be held in Japan on an annual basis, but due to the Corona disaster, this year's conference was held in an online format for the first time, and all audience members except for the presenters and secretariat on the Japanese side participated in the conference online. On the other hand, Taiwan has maintained zero new domestic cases of novel coronavirus infection, and the daily routine of the country has not changed significantly.
A scene from the online conference
This exchange conference was part of the "Arrangement between the Japan-Taiwan Exchange Association (Japanese side) and the Association for Relations with the East Asian Region (now the Taiwan-Japan Relations Association, Taiwan side) for the Establishment of a Framework for Cooperation on Regulation of Medical Products (Japan-Taiwan Pharmaceutical Regulatory Cooperation Arrangement)" concluded between Japan and Taiwan on November 5, 2013, In December of the same year, the "Japan-Taiwan Pharmaceutical Exchange Conference" was held in Taipei. The "Japan-Taiwan Pharmaceutical Regulatory Cooperation Arrangement" was established to establish a platform for mutual understanding and cooperation in pharmaceutical regulations between Japan and Taiwan, and to request cooperation from the regulatory authorities of Japan and Taiwan. Against this background, in addition to building a foundation for cooperation between the two countries, in-depth presentations and discussions are held on each topic, and a cooperative scheme for new drug review is underway for new drugs. At this year's exchange conference, 488 participants (246 from Japan and 242 from Taiwan) from the pharmaceutical and medical device industries shared the latest information on COVID-19 measures, pharmaceutical regulations, and the medical insurance system, and discussed issues of mutual concern. The participants also discussed the latest information on COVID-19 countermeasures, drug regulations, and the healthcare insurance system, as well as the challenges faced by both sides.
On the Japanese side, under the auspices of the Japan-Taiwan Exchange Association, 15 members from the Japanese regulatory authorities, 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. Yasuhiro Fujiwara, President, Pharmaceuticals and Medical Devices Agency (PMDA), Ms. Junko Sato, Director, International Affairs Department, PMDA, and 66 members from the Pharmaceutical Manufacturers Association of Japan, including Ms. Shoko Nakagawa, Executive Director of the Pharmaceutical Manufacturers Association of Japan. The number of participants from Japan totaled 246, including 15 from the Japanese regulatory authorities, 66 from the Pharmaceutical Manufacturers Association of Japan (PMAJ), 57 from the Japan Federation of Medical Devices Industries (JFMDA), and other general participants.
The Taiwanese side was led by the Taiwan-Japan Relations Association, and included Mr. Hui-Fang Chen, Deputy Director of the Food and Drug Administration, Ministry of Health and Welfare (TFDA), the Center for Drug Evaluation (CDE), the Central Health and Wellness Administration, Ministry of Health and Welfare (NHIA), Taiwan Research-based Pharmaceutical Research and Development Association (TRPMA), Taiwan Pharmaceutical Manufacturers Association (TPMA), and the Republic of China's Taiwan Pharmaceutical Research and Development Association (IRPMA), Taiwan Pharmaceutical Industry Association (TPMA), Taiwan Pharmaceutical Research and Development Association (IRPMA), Taiwan Pharmaceutical Industry Association (CAPA), Taipei Pharmaceutical Agents and Traders Association (TPADA), Taiwan Pharmaceutical Marketing Management Association (TPMMA), Taiwan Generic Products Association (TGPA), Republic of China Pharmaceutical Development Association (CPMDA), Taipei JCCI Pharmaceuticals and Medical Devices Division (JCCI PMDC), Taiwan Pharmaceutical Manufacturers and Traders Association (PMDA) (JCCI PMDC), the National Federation of Medical Devices Dealers Association of the Republic of China (TFMDCA), and the Taiwan Medical Devices Industry Association (TMBIA), with 242 participants from Taiwan.
In their opening remarks, Mr. Izuru Hanaki, Executive Director of the Japan-Taiwan Exchange Association, and Mr. Ching-Hong Lin, Deputy Secretary General of the Taiwan Association for Relations with Japan, gave congratulatory speeches and talked about the recent progress in cooperation between regulatory authorities and industry, including the pharmaceutical regulatory system for the global epidemic of new coronavirus infection, which was unimaginable in the previous conference, and how the two sides have been working together to harmonize pharmaceutical regulations. He expressed his hope that the two parties would harmonize their pharmaceutical regulations and deepen mutual understanding of medical insurance systems. The discussion on pharmaceuticals and medical devices continued from the previous meeting. First, both authorities gave updates on regulatory information in a keynote session for pharmaceuticals and medical devices, followed by an exchange of information on pharmaceutical regulations for COVID-19, and then a discussion on health insurance.
Keynote Speech
As regulatory updates on pharmaceuticals and medical devices, the PMDA from Japan and the TFDA from Taiwan presented the latest status.
The PMDA first introduced the background of the revised Pharmaceuticals and Medical Devices Act in Japan and its revisions, the response to COVID-19, and the Japan-Taiwan collaboration system. In the part of the revised Pharmaceutical Affairs Law, the PMDA explained the main points to be revised in order to "promptly deliver safe, high-quality, and innovative pharmaceutical products to patients. Regarding the rationalization of the approval review system, he introduced the legalization of the conditional early approval system and the pioneer approval system, the new approval system based on the characteristics of medical devices, and the clarification of clinical trial procedures for new clinical trials such as baskets and umbrellas, as well as ensuring the safety of subjects. In addition, as a response to COVID-19, he introduced the point that the environment is being improved to facilitate clinical trials by issuing a statement. In closing, he again expressed his gratitude for the generous donation for the Great East Japan Earthquake in 2011, and also mentioned the close collaboration between Taiwan and Japan, which has continued up to the 8th plenary session and the holding of workshops and Asian Training Center for Multiregional Clinical Trial (MRCT). The participants also expressed their hope for future collaboration not only between Taiwan and Japan, but also with other Asian countries and the world.
Taiwan introduced Medical Product Management, COVID-19, and collaboration with Japan. In addition, he explained about the review process for biosimilars, generics, and orphan drugs. In terms of COVID-19, he explained the importance of balancing the supply of medicines and preventing unnecessary hoarding of medicines by creating a platform for supply and managing information. He also explained how the platform was able to prevent unnecessary hoarding of medicines by creating a platform for supply and managing information. Finally, he shared that under the cooperative new drug review scheme with Japan, two cases have been approved and two cases are currently under review. He stated that he would continue to actively promote exchanges not only with Japan but also with authorities in other countries.
Issues of Regulatory Affairs for COVID-19
In this session, the current status of the response to COVID-19 was introduced.
In Japan, as a countermeasure against novel coronavirus infection, priority review is given to drugs and medical devices for novel coronavirus infection or related symptoms, and when urgent deliberations are needed at the Clinical Trial Review Committee, e-mail or online meetings are considered so that the development of necessary drugs and devices can proceed without delay. In addition, he explained that flexible measures are being taken to enable prompt development and approval review, such as allowing the use of photocopies and electronic signatures as current documents under certain conditions for signatures on consent documents, etc. In addition, he reported that the JCIA has decided to strengthen international collaboration in vaccine development through the International Cooperation of Medicinal Regulatory Authorities (ICMRA)/World Health Organization (WHO) and to participate in the COVAX Facility.
In Taiwan, it used to take more than 10 years to develop a vaccine, but due to the amendment of the law, in special cases such as COVID-19, manufacturing, importation, and procurement are allowed upon submission of relevant documents, promoting expedited review, and three vaccines are currently in the clinical trial stage, he introduced. While the Ministry is actively providing technical and financial support for promising vaccines, the development of a vaccine for COVID-19 is currently under discussion with experts because the standard factors to be evaluated are not clear and the evaluation of efficacy and safety after the launch of the vaccine is an important issue, and international cooperation is important. The importance of international cooperation was confirmed.
Health Insurance System
In this session, both authorities introduced the NHI drug price system.
Japan introduced the NHI drug price system and calculation rules. The rules for calculating new drug prices were explained extensively, 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.
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 under a set total annual medical cost expenditure. He also introduced the actual situation of the review period. In addition, he also introduced the Managed Entry Agreement (MEA), which has been introduced as a countermeasure against the current financial pressure and the increase in cost expenditure. Finally, he introduced a project called "Horizon Scanning," in which the cost of drugs to be applied for in the future is registered in advance for the purpose of calculating a budget plan in advance in order to improve the current situation of financial pressure. The conference has been held every year since its inception in 2013.
Health Insurance System 4.
The exchange conference, which began in 2013, has been held alternately each year and this year marked the 8th meeting. Working groups on pharmaceuticals and medical devices have been established between the two authorities, and personnel exchanges and cooperative schemes for new drug review are underway. Although the face-to-face meeting could not be held due to the global outbreak of COVID-19, we were able to have a lively discussion and understand how both authorities are incorporating innovation and other aspects of pharmaceutical regulation into their regulations. In addition, the participants were able to understand how both authorities are incorporating innovation and other aspects into their regulations in the area of pharmaceutical regulations. I am confident that the two authorities will continue to cooperate with each other in the future. I hope that the next year's meeting will be held face-to-face, and that the public and private sectors will promote regulatory cooperation and understanding between Japan and Taiwan in the areas of pharmaceuticals and medical devices under the framework of this meeting.
( Osamu Kagawa, Hisashi Kiriyama, Hayato Deki, Taiwan Team, Asia Subcommittee, International Committee)