Topics The 11th Japan-Taiwan Pharmaceutical Exchange Conference held
The 11th Taiwan-Japan Pharmaceutical Exchange Conference was held on October 5, 2023, in a hybrid face-to-face and online format. 2023 was the first time since 2019 that the conference was held in Taipei, Taiwan, and many participants from Taiwan's pharmaceutical authorities and industry, including Mr. Wu Shu-mei, Director of the Food and Drug Administration (TFDA), Ministry of Health and Welfare, Taiwan, participated. The event was attended by many participants from Taiwan's pharmaceutical authorities and industry. A total of 24 people from the Ministry of Health, Labor and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA), and industry also visited Taiwan from Japan.
Group photo of the day by the organizers and sponsors
This exchange meeting is the 11th since the first meeting was held in Taipei in December 2013, based on the "Arrangement between the Interchange Association Foundation (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 Regulation of Medical Products" concluded on November 5, 2013 (abbreviated as "Japan-Taiwan Pharmaceutical Regulatory Cooperation Arrangement"). This is the 11th meeting since the first meeting was held in Taipei in December 2013 based on the "Japan-Taiwan Regulatory Cooperation Arrangement". The "Japan-Taiwan Regulatory Cooperation Arrangement" is intended to establish a platform for mutual understanding and cooperation on pharmaceutical regulations between Japan and Taiwan, and to request cooperation from the regulatory authorities of Japan and Taiwan. Against this backdrop, in-depth presentations and discussions have been held on various topics, while promoting the formation of a foundation for cooperation between the regulatory authorities and industries in Japan and Taiwan. In the area of new drugs, a cooperative scheme for new drug review has been established and is being implemented to ensure that new drugs approved in Japan are launched efficiently and promptly in Taiwan. This year's exchange conference was attended by more than 650 participants from the pharmaceutical and medical device industries in Japan and Taiwan (approximately 200 on-site and 450 online). 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 the two countries was shared.
The Japanese side 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 Daisuke Koga, Director of the Office of International Pharmaceutical Regulations, Pharmaceutical Affairs Bureau, Ministry of Health, Labour and Welfare (MHLW), Shinji Yada, Director of PMDA, and other Japanese regulatory authorities; Shoko Nakagawa, Executive Director (International Affairs) of the Pharmaceutical Manufacturers Association of Japan (PMDA); the Japan Federation of Medical Devices Industry (JFMDA); and other representatives from the pharmaceutical industry.
On the Taiwanese side、 Under the auspices of the Taiwan-Japan Relations Association、 Food and Drug Administration, Ministry of Health and Welfare（TFDA）・ Center for Drug Evaluation and Inspection（CDE）・ Central Health Insurance Bureau, Ministry of Health and Welfare（NHIA）・ Pharmaceuticals and Medical Devices Division, Taipei Chamber of Commerce and Industry（JCCI PMDC）・ Taiwan Pharmaceutical Manufacturers Association（TPMA）・ Taiwan Research and Development Center for Biotechnology and New Drugs Taiwan Pharmaceutical Manufacturers Association (TPMA), Taiwan Research and Development Pharmaceutical Manufacturers Association (TRPMA), Taiwan Generic Products Association (TGPA), Republic of China Pharmaceutical Development Association (CPMDA), Taiwan Medical Device Industry Association (TMBIA), and National Federation of Medical Device Dealers Associations of the Republic of China (TFMDCA).
Keynote Speeches
As regulatory updates on pharmaceuticals and medical devices, the Taiwanese side presented the TFDA and the Japanese side presented the latest status of the PMDA.
PMDA explained that the environment surrounding drug discovery in Japan has changed, that the number of new drugs originating from Japan has been decreasing, that drug discovery capabilities have been declining, and that PMDA has established a system to support drug development from the early stage. In order to improve access to innovative drugs and to deepen pharmaceutical cooperation between Japan, the U.S., and the EU, PMDA has established overseas offices in Asia and the U.S. He introduced that in Asia, PMDA is working with regulatory authorities, and in the U.S., PMDA is considering and promoting cooperation with industry, such as supporting development in Japan by venture companies and others.
TFDA explained the latest trends in drug safety monitoring, regulations on the development of regenerative medicine, and decentralized clinical trials (DCT). Regarding the outlook for pharmaceuticals and medical devices, he introduced that information can be obtained more conveniently from platforms and that they are considering formulating policies with an eye to the future. He also talked about international regulatory collaboration, including quality control.
Promotion of clinical trials using RWE/RWD
The current status of Real World Evidence (RWE)/Real World Data (RWD) initiatives was introduced.
The Taiwanese side introduced their biobank initiatives. Taiwan has enacted the Biobank Management Act, which has three features: (1) broad consent (no need to obtain new consent for information collected in biobanks), (2) data safety management, and (3) commercial benefit feedback. The Act has three features: (1) broad consent (no new consent is required for information collected in biobanks), (2) data safety management, and (3) commercial benefit feedback. There are several biobanks in Taiwan, but they have not been effective, so the National Biobank Consortium of Taiwan (NBCT) was established in October 2019 to promote collaboration among biobanks and allow them to use each other's information. The NBCT includes genomes as well as blood samples and aims to be an important biotech resource. The NBCT also consists of 34 biobanks, and data is collected from electronic health records; the NBCT is in the process of creating a Common Data Model and is using health insurance data. As a pilot project of Precision Medicine using NBCT, 2000 RWDs on six types of cancer are being collected, By August 2023, data for 1164 patients had been collected, and some cases have been linked to treatments.
The Ministry of Health, Labour and Welfare (MHLW) explained that it is difficult to conduct clinical trials for diseases with a small number of patients, such as rare diseases, and as a result, the development of drugs for rare diseases and intractable diseases has been difficult. In order to promote the use of RWD, he mentioned that Japan has established guidelines for the use of registries for drug approval applications, guidelines for the concept of ensuring the reliability of registries, and a consultation system. The promotion of appropriate use of RWDs is expected to make it possible to conduct evaluations in shorter and less expensive trials with fewer patients instead of lengthy and costly clinical trials.
Cooperative Scheme for New Drug Review
In this session, the current status and future direction of the New Drug Review Collaboration Scheme were introduced.
The PMDA reviewed that prior to 2017, when the pilot of this scheme started, there was no international Reliance Scheme, and that although there were cases of utilization of review reports, each country was only analyzing the other country's and utilizing them on its own. The pharmaceutical authorities in each country need to introduce innovative drugs into their countries, and the Reliance Scheme has become increasingly important. As for the further expansion of the new drug indication (within one year after approval), the two authorities would like to work together to improve the way of handling post-marketing safety data, etc. As the next step, they would like to expand the scope of the new drug indication to countries other than Japan and Taiwan, expand the range of indications from new drugs, etc., and expand Q&A to promote the use of the new drug. The TFDA is considering expansion to countries other than Japan and Taiwan, expansion of the scope from new drugs to those with expanded indications, and expansion of Q&A to promote use.
The TFDA introduced five cases that have been utilized to date. Although the number of cases in which the scheme has been used is still limited, various measures are being considered to promote its use, and we hope that the scheme will become more user-friendly in the future and that the accumulated experience will further develop the scheme.
Regenerative Medicine
Regulations and examples of approved regenerative medical products were presented.
The TFDA has informed that Regenerative Medical Practice must comply with the GTP, that Regenerative Medical Products must comply with GMP, GDP, and GCP, and that it is necessary to obtain permission, application, and approval from the TFDA, and that clinical trials for Regenerative Medicinal Products are divided into three categories according to risk level (Standard Review: 45 days, Need AC: 150 days, Fast Track System Application: 30 days). Clinical trials for Regenerative Medicinal Products are divided into three categories (Standard Review: 45 days, Need AC: 150 days, Fast Track: 30 days) according to the risk level, and the review process is the same as for new drugs, The review process is the same as that for new drugs, and the TFDA discloses the time control status of applications and approvals on its website so that companies can monitor the progress.
The PMDA also mentioned that the Act on the Safety of Regenerative Medicine (Safety Act) and the Act on the Pharmaceutical and Medical Devices (PMD Act) were enacted in Japan in 2014, and that the PMDA will review the Safety Act and the PMD Act in the near future, Regarding the Safety Act, a working group has been established to review the Act and the inclusion of Gene Therapy in the Act is under consideration. In addition, the PMDA has disclosed the review reports of all products in English.
Health Insurance System
Both authorities introduced the NHI drug price system.
The MHLW introduced the situation of medical and drug costs in Japan, the NHI drug price system and calculation rules, and the cost-effectiveness evaluation system. Regarding the NHI drug price calculation rules for new drugs, he explained that a special additional fee is added when a drug is recognized as useful or novel in order to promote innovation, and that the revision rate of the NHI price revision is determined by considering the difference between the NHI price and the prevailing market price.
NHIA shared the current status of the insurance system and drug price system in Taiwan. He also mentioned that new drugs such as cell therapy and genome therapy are being introduced in Taiwan, so there are new challenges in terms of health insurance, and that Conditional Listing is being considered as a measure to speed up the process of insurance coverage. He also mentioned that he is considering Conditional Listing as a measure to increase the speed of insurance coverage.
The issues of drug lag and drug loss have been highlighted in recent years, and we believe that it is necessary to establish a mechanism to attract investment and improve patients' access to medicines by making transparency and predictability clearer and making the pharmaceutical market more attractive through cooperation between the public and private sectors.
In addition, we visited NHIA the day after the Taiwan-Japan Pharmaceutical Exchange Conference and exchanged views on a better insurance system.
Mr. Tatsuya Koyama, a member of the Pharmaceutical Manufacturers Association of Japan (PMAJ) International Committee, and Mr. Chongliang Shi, Chief of the NHIA (photo on the right)
Summary
This exchange conference, which began in 2013, is now in its 11th year. In the course of our past efforts, we have made steady progress in harmonization and collaboration between the two authorities in new drug cases, including the review of the GCP inspection system in Taiwan in 2015, the addition of Japan to Taiwan's simplified review system in 2016, and the publication of a position paper on a collaborative scheme for new drug review between Japan and Taiwan in 2019. We feel that it is essential to continue to communicate through this exchange conference to deepen mutual understanding and trust between the pharmaceutical authorities and industry.
The conference is scheduled to be held in Japan in 2024. It is my hope that the public and private sectors will further develop their collaboration to date, promote regulatory harmonization and cooperation regarding pharmaceuticals and medical devices in Japan and Taiwan, and mutual understanding of each other's regulatory systems, and build a system in the public and private sectors that can deliver products to patients who need them as quickly as possible.
( Tatsuya Koyama and Shingo Ikegami, Taiwan Team, Asia Subcommittee, International Committee)