Topics The 10th Japan-Taiwan Pharmaceutical Exchange Conference held
On October 20, 2022, the "10th Taiwan-Japan Pharmaceutical Exchange Conference" was held at the Nihonbashi Life Science Building (Chuo-ku, Tokyo). The day was conducted in a hybrid format of on-site and online, and was the first time in three years since 2019 that the event was held in person. Thirty-four participants from Taiwanese authorities and industry, including Mr. Wu Shu-mei, Chief of the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare, came to Japan to participate in the conference.
Group photo of local participants on the day
This conference marks the 10th anniversary since the first "Japan-Taiwan Pharmaceutical Exchange Conference" was held in Taipei in December 2013. The occasion for the inauguration was the signing on November 5, 2013 of an arrangement (abbreviated as "Japan-Taiwan Pharmaceutical Regulatory Cooperation Arrangement") between the Japan Association for Taiwan Relations (Japanese side) and the Association for Relations with the East Asia Region (now the Taiwan-Japan Relations Association, Taiwan side) for the establishment of a framework for cooperation on the regulation of medical products. The main contents of this agreement include the establishment of a platform for mutual understanding and cooperation on pharmaceutical regulations between Japan and Taiwan, as well as requests for cooperation from the regulatory authorities of Japan and Taiwan.
The 10th meeting was attended by more than 500 participants from the pharmaceutical and medical device industries in Japan and Taiwan, who shared the latest information on the promotion of clinical trials using digital tools, countermeasures against novel coronavirus infection (COVID-19), and the medical insurance systems of both countries. In addition to forming the basis for cooperation between the two sides, in-depth presentations and discussions were held on each topic, and a new drug review collaboration scheme is underway to ensure that new drugs approved in Japan are launched promptly in Taiwan. Discussions on both sides of the issue have helped to further deepen mutual understanding toward the creation of innovative new drugs for the aging society in the Asian region.
The Japanese side of the exchange conference was hosted by the Japan-Taiwan Exchange Association and supported by the Pharmaceuticals and Medical Devices Agency (PMDA), the Pharmaceutical Manufacturers Association of Japan (PMAJ), and others. 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, Japanese regulatory authorities, Mr. Tatsuya Ito, Chairman of the International Committee, Pharmaceutical Manufacturers Association of Japan, and the Japan Federation of Medical Devices Industry (JFMDA).
The Taiwanese 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 National Health Insurance Agency (NHIA), the Pharmaceutical and Medical Device Committee of the Taipei Municipal Industrial and Commercial Association (JCCI PMDC), the Taiwan Pharmaceutical Manufacturers Association (TPMA), the Taiwan R&D-based Pharmaceutical Technology and New Drugs Taiwan Pharmaceutical Manufacturers Association (TPMA), Taiwan Research and Development of Pharmaceuticals and Medical Devices Association (TRPMA), Taiwan Research and Development of Pharmaceuticals and Medical Devices Association (IRPMA), Taiwan Generic Products Association (TGPA), Republic of China Pharmaceutical Development Association (CPMDA), Taiwan Medical Device Industry Association (TMBIA), and National Federation of Medical Device Trade Associations of the Republic of China (TFMDCA).
The conference will begin with a keynote session on regulatory information from both authorities, followed by discussions on the promotion of clinical trials using digital tools, the sharing of various measures taken by both Taiwan and Japan in response to COVID-19, and medical insurance. The discussion was also related to medical insurance. The following is a summary of the discussions.
Keynote speeches
As regulatory updates on pharmaceuticals and medical devices, the TFDA from Taiwan and the PMDA from Japan presented the latest status.
The PMDA stated that the cooperation between Japan and Taiwan had reached its 10th anniversary and that the most significant achievement was that the two sides had been able to continue working closely together for such a long period of time. The PMDA also introduced updates on major Japanese pharmaceutical regulations, the concept of vaccine evaluation for novel coronavirus, remote Good Clinical Practice (GCP) investigation, Q&A on clinical trials under the COVID-19 pandemic, e-informed consent, etc. The PMDA also presented the latest information on the Japanese regulatory framework for the development of vaccines against novel coronaviruses. The meeting concluded with a discussion on the future of various cooperative efforts. Finally, he informed the audience that he would like to continue to promote various collaborations and celebrate the 20th anniversary in a grand way.
TFDA introduced the Emergency Use Authorization (EUA) for COVID-19 vaccine, regenerative medicine, real-world data for drug applications, and the latest developments in clinical trials and medical devices. e-Labeling introduced five pilot programs underway, and the possibility of linking electronic medical records and other systems for medical use. He also introduced the future vision of e-labeling, including five pilot programs underway and the concept of linking e-labeling with electronic medical records and other systems for the benefit of medical care. He concluded by expressing his gratitude to Japan for the valuable experience gained through the past collaboration and his hope to actively pursue further collaboration in the future.
10th Anniversary Session
The conference also included a session to commemorate the 10th anniversary of the TFDA. After that, six panelists discussed topics related to the past, such as what has been achieved in the past 10 years of collaboration and challenges that have yet to be resolved, as well as what should be done to lead other Asian countries, what should be done to build evidence from Asia, and what should be done to build evidence from Asia. The panelists also exchanged opinions on topics related to the present and future, such as what should be done to lead other Asian countries, what should be done to build evidence from Asia, and how to promote collaboration between Japan and Taiwan in the next 10 years.
It was also noted that Japan and Taiwan have been cooperating and taking measures from a scientific perspective based on regulatory science, and that it is very important to continue to reflect new technologies in regulations from a scientific perspective in the future. In order to continue to cooperate and lead Asia in the future, it is important to collect data and share knowledge based on the past efforts. He also stated that it is important to look ahead not only to the next 10 years, but also to the 10 years beyond that.
3. promotion of clinical trials using digital technology 4.
In this session, the current status of efforts related to digital tools to promote clinical trials was introduced.
PMDA introduced that ICH E7 is being revised to accommodate the diversification of clinical trials, and that distributed clinical trials (DCT) were also mentioned in the revision. Basically, subjects need to visit the hospital to undergo testing, but the COVID-19 epidemic has restricted medical care, which has led to digital-based DCTs, and online medical care and wearable devices have made it possible to reduce the frequency of visits. He stated that he expects that in the future, by maximizing the advantages of both face-to-face and remote services, and by optimizing their combination according to the clinical trial design, efficient and effective clinical trials will be possible.
TFDA introduced the use of SNS for patient registration, the fact that all clinical trials that have been started are registered in a database so that they can be searched by anyone, and the fact that digitization is being promoted as needed, starting with simple processes and processes that do not affect the safety assurance of trial subjects. He stated that clinical trials using digital tools in Taiwan have just started, but that he would like to promote close cooperation with related parties to build a better clinical trial system for many participants and medical institutions.
COVID-19
In this session, the current status of efforts for COVID-19 was introduced.
PMDA introduced the status of COVID-19 and the efforts of the pharmaceutical regulatory authorities. It was introduced that in Japan, there are no action restrictions in the 7th wave, and that waterfront measures will be relaxed from September 7, 2022, and that the infection environment measures have entered a new phase. He also introduced the special approval and the newly introduced emergency approval system to expedite the introduction of vaccines and therapeutics. The TFDA expressed its desire to continue to work with the countries concerned to solve the problem.
The TFDA introduced the establishment of a supply database platform to check the status of drug stockpiles in the country, a patient registration platform, and safety monitoring efforts for the COVID-19 vaccine, and shared that excellent efforts are being made quickly and appropriately through the use of digital technology. The session was attended by the two authorities.
Health Insurance System
In this session, both authorities introduced the NHI drug price system. The MHLW introduced the NHI drug price system, calculation rules, and cost-effectiveness evaluation system. The MHLW introduced a wide range of new drug calculation rules, including the Comparable Drug Efficacy Comparison 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. He also mentioned the "Pharmaceutical Industry Vision 2021" and stated that pharmaceuticals are positioned as an important item for economic security.
NHIA shared the current status of the insurance system and drug pricing system in Taiwan. It is important to make the system more transparent and predictable, and to work with the public and private sectors to make the pharmaceutical market more attractive to attract investment and improve access to healthcare for patients.
He expressed his desire to strengthen operations related to insurance reimbursement by making full use of systems such as Horizon Scanning, which enhances budget predictability regarding future new drugs, Health Technology Assessment (HTA), which evaluates the appropriateness of drug prices at the time of approval, and Health Technology Reassessment (HTR), which reassesses cost-effectiveness after approval.
Summary
This year's conference marked the 10th anniversary of the exchange conference, which began in 2013. In the past 10 years, the GCP inspection system in Taiwan was reviewed in 2015, Japan was added to the simplified review system for new drugs in Taiwan in 2016, a position paper on a new drug review collaboration scheme between Japan and Taiwan was issued in 2019, and in 2022, a new regulatory system for regenerative medical products will be established in Taiwan based on the Japanese regulations for regenerative medical products, etc. In 2022, Taiwan will establish a regulatory system for regenerative medicine products based on Japan's regulations for regenerative medicine products, and harmonization and collaboration between the two authorities is steadily progressing.
The restrictions imposed by COVID-19 have been gradually eased, and for the first time in three years since 2019, the meeting could be held in person, allowing for lively discussions. Regarding the efforts of both sides, it was introduced that measures are being taken flexibly and promptly, and it was felt that it is essential to continue to communicate continuously between the two authorities to deepen mutual understanding and trust.
The 2023 conference is scheduled to be held in Taiwan. I hope that the past 10 years will lead to the next 10 years, and that the public and private sectors will promote regulatory harmonization and cooperation regarding pharmaceuticals and medical devices in Japan and Taiwan, as well as a better understanding of each other's regulatory systems.
( Tatsuya Koyama and Shingo Ikegami, Taiwan Team, Asia Subcommittee, International Committee)