Topics The 10th Japan-Thailand Joint Symposium" held

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The 10th Japan-Thailand Joint Symposium was held on January 16, 2024, hosted by the Food and Drug Administration (FDA) of Thailand and the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan. The symposium was attended by more than 200 participants from the Thai and Japanese regulatory authorities and various industries including the pharmaceutical industry.

This symposium aims to deepen mutual understanding between Japanese and Thai regulatory authorities and to form the basis for cooperation in pharmaceutical and medical device regulation and development in both countries in accordance with the Memorandum of Cooperation on Regulatory Cooperation for Pharmaceuticals and Medical Devices (MOC) signed in April 2018 between the Thai FDA and the Ministry of Health, Labour and Welfare. As this was the 10th anniversary symposium, the participants reviewed the 10 years of collaborative cooperation, including the joint symposium that started in 2013, and based on the experience, it was confirmed that the mutually beneficial relationship will be further developed to continue the collaborative cooperation for the next 10 years.

Participants in this symposium from Japan included the PMDA, the Ministry of Health, Labour and Welfare, pharmaceutical association member companies, and member companies of the Japan Federation of Medical Devices Associations (JFMDA), and from Thailand, the Thai FDA and the healthcare industry in Thailand.

The symposium was opened with opening remarks by Mr. Narong APHIKULVANICH, Secretary-General of the Thai FDA, and Mr. Yasuhiro Fujiwara, President of PMDA. In addition, as this was the 10th anniversary of the symposium, a Memorial Session for 10th Symposium "Regulation and clinical trials" was held to discuss the efforts of both countries to promote joint clinical trials in Asia, including Thailand. The session featured a lecture on the efforts of the two countries to promote joint clinical trials in Asia, including Thailand.

The session also shared the current regulations on pharmaceuticals, regenerative medicine products, and medical devices in both countries. This section focuses on the presentations related to pharmaceuticals.

Memorial Session for 10th Symposium

The Thai FDA indicated that the number of clinical trials in Thailand is 440 (ClinicalTrials.gov: as of January 3, 2024), the highest in the Southeast Asian region, but still not enough, and that they would like to increase the number of clinical trials through systemization and efficiency improvement. In addition, from a regulatory perspective, he explained that the current product-based authorization has been changed to Clinical Trial-based Authorization, which requires the submission of materials and review period according to the risk of the clinical trial (3 levels).

Chulalongkorn University (Bangkok) introduced the environment for conducting clinical trials in Thailand, where Clinical Research Coordinators (CRC) are assigned at university hospitals such as Chulalongkorn University and hospitals under the jurisdiction of the Thai Ministry of Health. He also touched on Decentralized Clinical Trial (DCT), saying that by applying digital technology, it will be possible to realize patient-centered clinical trials in which hospitals approach patients. He mentioned human resource development, international collaboration, digitalization, and system improvement in Thailand as key points for promoting clinical trials in the future. International collaboration on clinical trials is particularly important, and he introduced that they have begun collaborating with Nagoya University on CD19-targeted CAR-T cell therapy.

PMDA informed the audience that PMDA and MHLW are working to strengthen the foundation for conducting clinical trials in Asia and contributing to the development of future drugs and medical devices. As part of such efforts, he cited the Asian clinical trials network for cancers (ATLAS) being promoted by the National Cancer Center (NCC) as an example and explained the importance of Thailand's role in promoting the expansion of such a network and creating drugs and medical devices originating from Asia. He also mentioned the importance of Thailand's role in promoting the expansion of these networks and the creation of new Asian medicines and medical devices, as well as further collaboration between Japan and Thailand. He also mentioned that PMDA plans to establish an Asian base in Bangkok by 2024, where it will provide support for the smooth progress of multiregional clinical trials conducted by academia and companies.

NCC introduced the ATLAS project and the MASTER KEY study and Project CAD study that are being conducted within the project. He also mentioned the challenges of clinical trials in Thailand, such as further strengthening the support system within facilities and streamlining the review process by the ethics committee. He also touched on DCTs, citing the advantages of DCTs, including improved access to clinical trials for patients in remote areas, simplified ethics review and monitoring at neighboring hospitals (partner sites) where testing is outsourced, and promotion of patient enrollment and cost reduction. On the other hand, as pharmaceutical issues for DCT, he said that it is necessary to discuss with the regulatory authorities the scope of tests that can be outsourced to partner sites, the assurance of the signature of the patient for eConsent (a method of obtaining consent to participate in clinical trials using electronic tools), and the conditions for sharing medical information via the Internet with partner sites. The need to take action is being addressed in consultation with regulatory authorities. In addition, the Pharmaceutical Manufacturers Association of Japan (PMAJ) has started cross-border DCT with Thailand, and is preparing to allow Thai medical institutions to participate in clinical trials conducted in Japan as partner sites.

The Pharmaceutical Manufacturers Association of Japan (PMAJ) asked about the approval process for clinical trials in Thailand, and whether approval by the Local Research Ethics Committee (LREC) of each site is also required after approval by the Central Research Ethics Committee (CERC), The Thai FDA responded that they would like to establish a system to shorten the review period by the Ethics Committee. CERC also indicated that they would like to work with each facility to simplify the procedures and improve the system so that more facilities can be automatically approved, and expressed their opinion that discussions with the Thai FDA are necessary, including on the cost aspect. For pharmaceutical companies, the speed to launch clinical trials is important, and it is hoped that the shortening of the review period will further promote clinical trials in Thailand in the future.

Regulatory Update

The Thai FDA introduced that 13 regulations related to drug registration, renewal, and clinical trials have been revised in order to comply with new pharmaceutical regulations and international standards. Regarding the renewal of registration of drug registration certificates, he said that guidance for renewal of registration based on quality, efficacy, and safety information has been notified in June 2023. He also talked about the registration review process for pharmaceutical products. In addition to the normal review process, there are two simplified review processes: a simplified review process using the review reports of the PMDA and other reference regulatory authorities, and a simplified review process using the World Health Organization (WHO) Collaborative Registration Procedure (CRP) (*1). (CRP) *1 as a simplified review process.

He stated that since 2012, the PMDA has achieved the fastest level of review speed in the world, and that the predictability of review has increased and the drug lag has been eliminated as a result. On the other hand, as current issues, he mentioned the so-called drug loss problem, in which some drugs, such as venture drugs, orphan drugs, and pediatric drugs, have not been developed in Japan, and the problem of insufficient supply of generic drugs. The Ministry of Health, Labour and Welfare (MHLW) is currently studying these issues from the viewpoint of development promotion and pharmaceutical regulations. Regarding international collaboration and reliance, he introduced that Japan, in addition to Thailand, the Philippines, and Indonesia, has been adopted as the reference regulatory authority for Malaysia's simplified drug review system from January 1, 2024, and that Japan is working to promote regulatory harmonization in the Association of Southeast Asian Nations (ASEAN). He informed the audience that Japan is working to promote regulatory harmonization in the Association of Southeast Asian Nations (ASEAN).

A participant asked PMDA about its efforts to shorten the review period. PMDA explained that there are two types of lags: one is the lag in the timing of the start of development between overseas and Japan, and the other is the lag in the number of review days by the review authorities. Regarding the lag in the number of review days, PMDA has solved the problem by increasing the number of reviewers and improving the efficiency of the review process. Regarding the lag in development, PMDA has been providing information in English so that people overseas can understand that Japanese pharmaceutical regulations are in international harmony. The Thai side showed a high level of interest in the Japanese review system.

Pharmaceutical Session

The Thai FDA made a presentation on its efforts to speed up drug development in Thailand. The Thai FDA is promoting policies under the 6Ss of Speed, Safety, Satisfaction, Supporter, Sustainability, and Security, and as a change over the past year, they have shifted 100% to e-submission and have become completely paperless from September 2023. The change over the past year has been to move 100% to e-submission and to go completely paperless starting in September 2023. He also introduced other initiatives such as resource management, increasing the number of reviewers, and changing from a Safety Monitoring Programme (SMP) to a Risk Management Plan (RMP) for drugs. The approval process for low-risk drugs is being simplified, and for high-risk drugs, strong evidence is being sought. They are trying to establish an approval process suitable for Thailand by adopting an ingredient-based review for low-risk drugs, referring to the U.S., Australia, Canada, and other countries. He also expressed his appreciation for the support of the Japan International Cooperation Agency (JICA) and the PMDA, and indicated that the regulatory authorities in Japan and Thailand have a strong relationship of trust with each other.

The Pharmaceutical Manufacturers Association of Japan (PMDA) asked whether the e-platform would allow companies to check the current stage of the review process, and the Thai FDA responded that it was improving Skynet to allow both the regulatory authorities and companies to monitor the progress of the review process. This is expected to increase the transparency and predictability of the review process.

Conclusion

The 10th Japan-Thailand Joint Symposium was a fulfilling and successful symposium befitting the 10th anniversary, in which the 10 years of collaborative efforts were reconfirmed and reviewed for further development on the basis of these efforts, and topics related to clinical trials were included, among others, In addition, topics related to clinical trials were included in the symposium. We, the Pharmaceutical Manufacturers Association of Japan (PMAJ), would like to take advantage of this opportunity to promote the framework between industry, academia, government, and medicine so that innovative pharmaceutical products can be delivered to the people of both countries as soon as possible.

( Kei Mabuchi, Thailand Team Leader, and Keiichiro Kondo, Sub-Team Leader, International Committee, Asian Division)

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