Topics Held the 3rd Japan-Vietnam Joint Symposium
The 3rd Japan-Vietnam Joint Symposium" was held on November 29, 2022, hosted by the Pharmaceuticals and Medical Devices Agency (PMDA) and the Vietnam Drug Administration (DAV). The Pharmaceutical Manufacturers Association of Japan (PMAJ) and the Vietnam-Japan Alliance for Medicinal Products (JPAV) cooperated in the operation of the symposium as supporting organizations. The symposium was held for the first time in two years to discuss the regulatory authorities' response to the new coronavirus infection (COVID-19), the digitalization of the drug review system, and international cooperation to provide products that meet the needs of patients in Asia. The two authorities presented on three topics: regulatory response to COVID-19, digitization of the drug review system, and international collaboration to provide products that meet the needs of patients in Asia.
Symposium
Introduction
This symposium was held in an online format, following the second symposium in December 2020. Of the 137 total participants, nearly 40% watched the symposium in Vietnamese, indicating a high level of interest from Vietnam.
Opening remarks were made by Ms. Junko Sato, Director of PMDA's International Division, and Mr. Vu Thi Hiep, Deputy Director of DAV's Legal Affairs and Inspection Division. Ms. Sato expressed her pleasure and gratitude for holding the third symposium, although there was a time when the symposium could not be held due to the COVID-19. He also expressed his hope that this symposium will lead to stronger cooperation between the two countries, and that the people of Vietnam will be able to access a wide range of medicines quickly.
1) Regulatory response to COVID-19
On the Japanese side, Mr. Masahiko Doi, Chief Specialist, Asia Division 1, International Department, PMDA, introduced the response in Japan to prioritize the evaluation of COVID-19-related products, including regulatory flexibility, safety measures, and the establishment of an emergency approval system, as well as international collaboration, including information sharing and referencing experiences and measures to resolve issues with other countries as part of international activities. The Vietnamese delegation presented the DAV pharmaceuticals business management.
From the Vietnamese side, Dr. Nguyen Thi Minh Hoai, Deputy Director of DAV's Pharmaceutical Business Management Division, introduced the prevention and control of COVID-19 and future measures implemented so far. In order to enhance access to vaccines and therapeutics, an emergency conditional approval system for vaccines has been introduced, and the diversion of APIs licensed for importation to the manufacture of medicines for other purposes has been permitted. In addition, by shortening the administrative procedures for import licenses for vaccines, medicines, and drug ingredients, the Vietnamese Ministry of Health has conditionally approved nine vaccines and more than 20 therapeutic drugs. Future measures include amending the Pharmaceutical Law and reforming administrative procedures. We will also continue to consider applying a special scheme for import licenses for vaccines and medicines for the prevention of infectious diseases; promoting the production of COVID-19 therapeutics, technology transfer, perfecting mechanisms and policies for early access to new generation vaccines and biological products, and promoting international cooperation, and promote diplomacy for early access to vaccines and medicines for the prevention of the spread of infectious diseases.
2. digitization of the drug review system
From the Japanese side, Ms. Yuriko Takemura, Coordination Specialist, Asia Division 2, International Department, PMDA, gave a lecture on digitalization in Japanese approval applications, introducing the electronic application system as well as the flow of the Japanese new drug review system. She introduced not only the benefits of e-application introduction in terms of improved convenience and efficiency of review, but also the efforts for transitioning to e-application. Through pilot studies, issuing guidance and workshops, and establishing a consultation system, PMDA has been sharing information and cooperating with users in order to develop a system that is effective for both applicant companies and regulatory authorities. In addition, ideas for the future using the accumulated data were also introduced.
From the Vietnamese side, Mr. Le Xuan Hoanh, Deputy Director of DAV's Drug Registration Department, introduced the digitalization of DAV's review system and its milestones. Vietnam has started the transition to online submission of drug registration application materials in 2019. Registration renewal and new registration applications are already ready for online submission, and change applications are scheduled for implementation in January 2023. Although the transition to fully online review and processing is planned thereafter, there is an infrastructure limitation of 25 MB per file, and some large-volume application documents, such as clinical data, will continue to be accepted on paper. In the future, we are considering the introduction of AI, which is expected to speed up the document verification after receipt of application documents and the initial screening before document review. We believe that infrastructure must also be developed to make this a reality.
3. international collaboration to provide products that meet patients' needs in Asia
From the Japanese side, Mr. Sato, Director of PMDA's International Division, introduced PMDA's international cooperation activities, especially in Asia. In addition to cooperation with regulatory authorities in Asian countries through the activities of the Asian Training Center and collaboration with academia in Asia, he also introduced reliance efforts with several regulatory authorities in Asia that conduct reviews using Japanese review results. In explaining Japan's post-marketing safety measures and reexamination system for new drugs, he mentioned that Japan has not adopted a re-registration system like Vietnam, and that these systems have their own advantages and disadvantages. He also stated that convergence of regulatory systems with those of other countries could lead to early access to innovative medicines for their citizens.
Mr. Le Xuan Hoanh, Deputy Director of the DAV's Drug Registration Department, introduced the Expedited and Simplified Assessment from the Minister of Health's Circular regulating drug registration, which was promulgated in September 2022. This notification simplifies the procedure compared to the previous one. The scope of the expedited and simplified evaluations has been broadened; for example, changes of manufacturing location, which were previously reviewed in the general evaluation of new applications, are now subject to expedited evaluation. The expedited and abbreviated evaluations will apply to partially simplified quality dossiers and shorter review times. In the future direction, a review of the Pharmaceutical Affairs Law is being considered for the introduction of Reliance, and if all goes well, the new Pharmaceutical Affairs Law is scheduled to become effective in 2025.
Closing Remarks
At this symposium, Q&A sessions were set up for each theme, and both authorities responded to questions from the audience via text message; DAV also posed questions to PMDA, showing interest in the other authority's efforts and high expectations for Reliance.
In closing, Mr. Vu Thi Hiep, Deputy Director of Legal Affairs and Inspection, DAV, presented six proposals for future cooperation with PMDA, including regular meetings between the two authorities on substantive topics and the signing of an MOU to share review reports on new drugs and drugs for rare diseases. In response, Mr. Sato, Director of PMDA's International Affairs Department, stated that he would like to discuss these six proposals in detail in the future.
The industry is very encouraged by the increasing cooperation between the authorities of the two countries. We hope that the symposium will continue to serve as a public-private platform for both Japan and Vietnam to deepen understanding and cooperation between the two countries for the early access of pharmaceutical products.
( Masayo Higashiyama, Leader, Vietnam Team, Asia Committee, International Committee)