Topics The 7th Taiwan-Japan Pharmaceutical Exchange Conference" was held.
On October 1, 2019, the "7th Taiwan-Japan Pharmaceutical Exchange Conference" was held at the Zhang Rongfa Foundation International Convention Center (International Conference Center of the Chang Rongfa Foundation, Taipei, Taiwan). At the conference, participants shared the latest information on pharmaceutical regulations and medical insurance systems from the standpoints of pharmaceuticals, medical devices, and over-the-counter (OTC), and discussed issues of mutual interest between Japan and Taiwan. In addition, we were able to further deepen mutual understanding from the perspective of strategies for Asia, such as the use of big data to create innovative new drugs for an aging society, and the issue of drug price adjustments in health insurance.
The exchange conference was preceded by the signing of a five-point Memorandum of Understanding between Japan and Taiwan on November 5, 2013, including an arrangement between the Japan Association for Relations with Taiwan (on the Japanese side) and the Association for Relations with the East Asia Region (now the Taiwan-Japan Relations Association, on the Taiwanese side) to establish a framework for cooperation on medical product regulations (the Japan-Taiwan Pharmaceutical Affairs Regulatory Cooperation Arrangement), which was followed by the signing of a Memorandum of Understanding in December of the same year in Taipei. The first "Japan-Taiwan Pharmaceutical Exchange Conference" was held in Taipei in December of the same year. The main items agreed upon in the "Japan-Taiwan Regulatory Cooperation Arrangement" include the establishment of a platform for mutual understanding and cooperation in regulatory affairs between Japan and Taiwan, and a request for cooperation between the regulatory authorities of Japan and Taiwan. Since the second meeting, participants in the medical device and over-the-counter (OTC) drug industries have joined the forum, and each time, in-depth presentations and discussions are held on each topic, as well as on the formation of a cooperative foundation.
Group photo
The Japanese side was hosted by the Japan-Taiwan Exchange Association, and included Mr. Naoyuki Yasuda, Director of the Office of International Pharmaceutical Regulations, General Affairs Division, Pharmaceuticals and Consumer Affairs Bureau, Ministry of Health, Labour and Welfare; Mr. Kenichi Hayashi, Director, Pharmaceuticals and Medical Devices Agency (PMDA); Ms. Junko Sato, Director, International Division, PMDA; 14 representatives from Japanese regulatory authorities; Mr. Tadaharu Goto, President, Japan Pharmaceutical Manufacturers Association (JPMA); and 8 representatives from general associations. The total number of participants from Japan was about 30, including Mr. Ken Ken Hayashi, Director of the PMDA, Ms. Junko Sato, Director of the International Department of the PMDA, 14 from the Japanese regulatory authorities, Mr. Tadaharu Gofuji, President of the Pharmaceutical Manufacturers Association of Japan, and 8 from the Japan Medical Devices Federation, Japan OTC Pharmaceutical Association, and other general participants.
The Taiwan side was organized by the Taiwan-Japan Relations Association (TJRA), and included Mr. Shu-Mei Wu, Director of the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare, the Center for Drug Evaluation (CDE), the Central Health and Welfare Administration (NHIA), the Taiwan Research-based Pharmaceutical Research and Development Association (TRPMA), the Taiwan Pharmaceutical Manufacturers Association (TPMA), and the Taiwan Pharmaceutical Research Association (TARMA), Taiwan Pharmaceutical Industry Association (TPMA), Taiwan Pharmaceutical Research and Development Association (IRPMA), Taiwan Pharmaceutical Industry Association (TPMA), 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), Taipei Pharmaceutical Industry Association (TPADA) The 7th Exchange Conference was attended by about 250 participants, including the Taiwan Generic Products Association (TGPA), the Taiwan Generic Products Association (TGMA), the Pharmaceutical Development Association of the Republic of China (CPMDA), the Japan Chamber of Commerce and Industry, Taipei (JCCI PMDC), the National Federation of Medical Device Trade Associations of the Republic of China (TFMDCA), and the Taiwan Medical Device Industry Association (TMBIA).
The 7th edition of this exchange conference continued the discussion on pharmaceuticals and medical devices from 2018. First, the keynote session on pharmaceuticals and medical devices was followed by regulatory updates from both authorities, which was followed by breakout sessions for pharmaceuticals and medical devices respectively. The pharmaceuticals session was further divided into health insurance and OTC sessions.
In their opening remarks and congratulatory speeches, representatives from the regulatory authorities and industry spoke of the significance and expectations of the conference, and expressed the hope that, as the cooperative relationship between regulatory authorities and industry has been progressing more and more in recent years, a wide range of opinions would be exchanged at the conference to harmonize regulations on both sides and to deepen mutual understanding of health insurance systems. The PMDA expressed its hope to deepen mutual understanding between the regulatory authorities and the medical insurance system.
Regulatory Update
As regulatory updates on pharmaceuticals and medical devices, the PMDA from Japan and the TFDA from Taiwan presented the latest status.
At the beginning of the meeting, the PMDA introduced that Japan maintains the second longest review period in the world after the U.S., and that the review period for product groups has been consistent and is highly regarded internationally. At the review stage, the "Pioneering Review Designation System" was started on a trial basis in 2015 in order to approve groundbreaking products in Japan ahead of the rest of the world, and the fourth designation was made in April 2019, with 21 pharmaceutical products, 11 medical devices, 11 regenerative medicine products, and 1 in vitro diagnostic product having been designated to date. The second round of Pioneering Examinations was held in April 2019. In addition, the OncoGuide NCC Oncopanel System, designated under the second round of the Pioneering Review Designation System, was approved as a combination medical device on December 25, 2018, and the utilization of the Pioneering Review Designation System for such groundbreaking products is leading to improved patient access.Real In the utilization of World Data, it was reported that MID-NET (Medical Information Database Network) has been established and a paper summarizing this activity was published this year (Pharmacoepidemiol Drug Saf. 2019;28: 601-608).
The TFDA currently has two basic policies: "Protect" to ensure the quality, safety, and efficacy of drugs, and "Promote" to promote the establishment of an early approval system for innovative drugs. He also introduced the "Protect" to ensure the quality, safety, and efficacy of pharmaceuticals, and "Promote" to establish an early approval system for innovative drugs. E-labeling system and E-reporting system are also under construction with the aim of implementation after 2021, and various regulations in the field of Regenerative Medical Product (RMP) will be established and legalized by the end of this year. The TFDA's role in relation to pharmaceuticals and medical devices and its future prospects were also discussed.
2) Pharmaceuticals Session
In the pharmaceutical session, he introduced the status of ICH-E17, E-labeling, and the current situation related to health insurance.
E-labeling is being promoted to reduce the time and effort required to determine which is the latest version of the package insert, which is currently filed at pharmacies for each revision, and to enable anyone to obtain the latest package insert anywhere, since physicians in Japan have few opportunities to access paper versions of the package insert in the country where the division of labor has progressed. The advantages of e-labeling are accessibility, which allows the latest information to be obtained from anywhere; rangeability, which allows the XML format to be used in regional formularies and easily translated into other languages; and searchability, which facilitates searching of the contents. The three advantages of labeling are accessibility, which allows users to obtain the latest information from anywhere; rangeability, which is the use of XML format for regional formularies and translation into other languages; and searchability, which facilitates content search.
In Taiwan, the TFDA is working to improve accessibility, readability, and usability of attached documents, and currently provides an app developed by the TFDA that reads the QR code on the drug box to immediately access the attached document information. The app also provides a voice-reading function for the visually impaired. In particular, it was reported that OTC has already improved access by using standardized attachments to make them easier to understand and read on a variety of terminal devices.
Finally, both authorities introduced their drug pricing systems. Japan provided a detailed explanation on the existing NHI drug price system, including the new drug price calculation system, past experiences in reforming the system, and future prospects, while Taiwan explained the existing NHI drug price system, including the total payment system, NHI price listing, and post-marketing drug price survey. As major system changes, detailed introductions were made regarding cost optimization measures such as conditional reimbursement (Managed Entry Agreement, MEA), especially the payment system based on drug effectiveness (Risk Sharing Agreement, RSA), which came into effect in September 2018.
3. summary
This is the seventh exchange conference since its inception in 2013. Working groups on pharmaceuticals and medical devices have been established between the Taiwanese and Japanese authorities, and personnel exchanges are underway. In particular, a project to establish a drug review collaboration for pharmaceutical products is underway. In this session, information on ICH-E17 was exchanged, and initiatives to improve convenience, such as e-labeling, were discussed. I realized how essential it is to have continuous communication between the two authorities to deepen mutual understanding and trust. Furthermore, during this exchange meeting, the two authorities agreed to promote the exchange of information on new drug screening. This is a sign that the framework for cooperation between the two authorities is progressing.
The conference is scheduled to be held in Japan in FY2020. We hope that the framework of this exchange conference will be used to promote regulatory cooperation and understanding between Japan and Taiwan regarding pharmaceuticals, medical devices, and regenerative medicine products in the public and private sectors.
( Osamu Kagawa, Taiwan Team, Asia Subcommittee, International Committee)