Topics The 9th Japan-Thailand Joint Symposium held

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On January 17, 2023, the "9th Japan-Thailand Joint Symposium" was held under the auspices of the Food and Drug Administration of Thailand (Thai FDA) and the Pharmaceuticals and Medical Devices Agency (PMDA). Although the symposium had been held online due to the spread of new coronavirus infection (COVID-19), it was held in person for the first time in nearly four years, since the 6th Japan-Thailand Joint Symposium in 2019. In accordance with the Memorandum of Understanding on Cooperation in Regulation of Pharmaceuticals and Medical Devices signed between the Thai FDA and the Ministry of Health, Labour and Welfare in April 2018, this symposium aims to deepen mutual understanding between Japanese and Thai pharmaceutical professionals and form the basis for cooperation in pharmaceutical and medical device regulation and development in the two countries. The symposium featured sessions on pharmaceuticals, medical devices, and regenerative medicine, where the latest information on pharmaceutical and other regulatory issues in Japan and Thailand was shared and discussed, including efforts for efficient regulatory review in both countries.

The symposium was attended by the PMDA International Division, the Ministry of Health, Labour and Welfare, member companies of the Pharmaceutical Manufacturers Association of Japan (PMMA), and member companies of the Japan Federation of Medical Devices Associations (JFMDA) from Japan, and Mr. Paisarn DUNKUM, Secretary-General of the Thai FDA, Thai FDA, and Thai industry from Thailand. Mr. Paisarn DUNKUM, Secretary-General of the Thai FDA, from Thailand, as well as the Thai FDA and Thai industry. The symposium was opened with opening remarks by Mr. DUNKUM of the Thai FDA and Mr. Yasuhiro Fujiwara, President of PMDA.

They shared the current efforts related to COVID-19 in both countries, regulations on pharmaceuticals and medical devices, and post-approval monitoring methods for pharmaceutical products in both countries. This report focuses on the presentations related to pharmaceutical products.

The Thai FDA provided an update for 2022, referring to the ASEAN Joint Assessment and the review by the World Health Organization (WHO) or the Stringent Regulatory Authority (SRA, ICH member authorities prior to October 2015, etc.). He reported on the introduction of a system to accelerate the review process by participating in the Collaborative Registration Procedure (CRP) with reference to the ASEAN Joint Assessment, the World Health Organization (WHO), or the Stringent Regulatory Authority (SRA, e.g., ICH member authorities before October 2015).

For COVID-19 vaccine, the following three review procedures are used to obtain approval earlier than the normal review process.

The PMDA introduced its efforts in relation to COVID-19.

The special approval process based on Article 14-3 of the Pharmaceuticals and Medical Devices Act had been applied to products that had been approved and established in other countries. The scope of application has been expanded to include an emergency approval system that can be applied to drugs that have not been approved in other countries but whose efficacy can be presumed.

In this session, the Pharmaceutical Manufacturers Association of Thailand (PMA) asked questions on the simplified review and e-labeling, and received the following answers from the Thai FDA.

The Thai FDA is of the opinion that the use of expedited review may expand in the future, especially since many companies feel difficulties in submitting applications within two years after approval in the reference country.

The Thai FDA also explained their expectations for joint assessment and work sharing to achieve early access to medicines, as well as the Reliance Pathway System*1 and the WHO Collaborative Registration Procedure (CRP) for medicinal products. The review period for the regular review of a pharmaceutical product is 220 days. The normal review period for a pharmaceutical product is 220 days, but an abbreviated review (review period: 180 days) and a CRP (review period: 90 days) that refers to the review results of WHO and SRA countries have also been established to further accelerate the approval process.

In addition, the PMDA has begun to build a foundation to obtain approval ahead of other countries in Thailand, and there is a Priority Review (review period: 200 days) system that is applied to specific diseases (with designation) that are considered to be a national issue.

PMDA explained the special case of approval of Lemdecivir for COVID-19 treatment in Japan. Lmdecivir was approved in Japan promptly after receiving Emergency Use approval in the U.S., as shown below.

Factors that contributed to the early approval included close communication with the applicant prior to receiving Emergency Use approval in the U.S. on May 1, 2020, and the development of regulations that allowed for a quick response. It was also reported that an emergency approval system was also introduced in 2022 to approve products that have not been approved in other countries for diseases requiring urgent approval based on lessons learned from COVID-19. He also touched on the clinical trial consultation conducted by the PMDA, noting that most of the applications filed in Japan are subject to at least one clinical trial consultation during the development stage, and that the review period for new drugs is set at 9 months for priority review items and 12 months for regular review items, with the median being achieved every year. He also reiterated the importance of the Reliance Pathway, which reduces the burden on the regulatory authorities and directs resources to urgent and innovative cases.

In this session, the Pharmaceutical Manufacturers Association of Japan (PMAJ) was able to ask and receive answers to questions related to the simplified review process.

The view that the review will be continued under the ordinary review when the simplified review cannot be applied will lead to a reduction of risk on the part of the applicant, and may lead to an expansion of the use of the simplified review in the future.

The following three monitoring methods exist for post-approval risk management in Thailand.

In the case of COVID-19, the information collected in this way allows the Adverse Events after Vaccination (AEFI) Committee to provide feedback on the next vaccine administration.

PMDA compared pharmacovigilance in Japan, the U.S., and Europe, and explained the similarities between the countries based on the implementation of the ICH guidelines. In Japan, a reexamination system has been introduced, and for new active ingredients, information on safety, efficacy, and quality in actual clinical practice is collected and evaluated for eight years after approval to assess whether the approved items are appropriate. The importance of disclosing the timeline of each step in the PMDA's approval review process was also discussed as important to improve the work efficiency of both the authorities and companies.

The PMDA is collecting AEFI information provided by medical institutions and sharing it with the MHLW, and is working with outside experts to determine whether any new safety measures are needed. The International Cooperation of Medicinal Regulatory Authorities (ICMRA) is an organization that shares information with countries in Europe, the U.S., and Asia. We are also devising ways to effectively communicate with various stakeholders in Japan. In the area of pharmacovigilance, it is increasingly important to work closely with the Thai FDA, PMDA, and MHLW.

Conclusion

This "9th Japan-Thailand Joint Symposium" was the first face-to-face meeting in a long time. The symposium was very meaningful as we were reminded of the advantages of holding the symposium face to face, with detailed explanations of both countries' COVID-19 efforts and systems to accelerate screening, and a lively Q&A session. The symposium was a great opportunity to reaffirm the benefits of holding face-to-face meetings and to learn from each other's experiences of close exchanges during normal times, as well as to learn from each other's experiences in emergency responses and review systems. We hope to make the most of these opportunities for exchange so that innovative pharmaceutical products can be delivered to the people of both countries as soon as possible.

( Kenjiro Sasaki, Thailand Team, Asia Subcommittee, International Committee)

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