Overview
On August 29, 2024, to commemorate the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA) Asia Office (Asia Office) which is the first PMDA overseas office, “International Symposium for Asia Regulatory Coordination” was held in Bangkok, Thailand, co-hosted by the PMDA and the Ministry of Health, Labour and Welfare (MHLW). A total of about 120 participants joined the symposium, including H.E. Prof. TAKEMI Keizo, the Minister of Health, Labour and Welfare, Dr. FUJIWARA Yasuhiro, the Chief executive of PMDA, top level representatives from Asian regulatory agencies, and representatives of industry in Asian region.
In this symposium, purpose and activities of the Asia Office were introduced, and three sessions (Note) with an aim of strengthening regulatory cooperation in Asia were held. In these sessions, presentations were given from Asian regulators including the first Head of the Asia Office, Dr. KITAHARA Jun and representatives from medical institution and so on, followed by panel discussions.
(Note)
“Changes in the Regulatory Environment Surrounding the Asian Region and Responses”
“Challenges for Capacity Building of Asian Regulatory Authorities”
“Asia Clinical Trials and Collaboration with Asian Regulatory Authorities”
In each session, the perspectives on how PMDA will contribute through the Asia Office towards regulatory cooperation in Asian region and the expectation to the Asia Office were shared among regulators and organizations.
Organizer
Ministry of Health, Labour and Welfare, Japan (MHLW)
Pharmaceutical and Medical Devices Agency (PMDA)
Date / time
August 29th (Thursday) 2024, 9 AM to 4h30 PM ICT (UTC+7)
Location
The Okura Prestige Bangkok, 3rd floor, Grand ball room
Address：57, Park Ventures Ecoplex 57 Witthayu Rd, Lumphini, Pathum Wan, Bangkok, Thailand
Program
Please see attached for the details of the program[137.02KB].
Symposium
Keynote
The symposium commenced with the opening remarks by H.E. Prof. TAKEMI Keizo, the Minister of Health, Labour and Welfare, which highlighted various initiatives to strengthen cooperation in the health sector with Asian and Indo-Pacific countries, including the 'Global Health Vision of the Ministry of Health, Labour and Welfare' and further conveyed anticipation for the Asia Office to drive the development of "Ecosystem for Development of Pharmaceuticals and Medical devices” across Asia.
Following the opening remarks by H.E. Prof. TAKEMI, Dr. FUJIWARA Yasuhiro, Chief Executive, PMDA gave presentation which included the background and purpose of the Asia Office, and introduction of the PMDA’s Purpose which indicates PMDA’ direction. From Dr. KITAHARA Jun, Head of the Asia Office, a presentation on the direction of the Asia Office and the aim for collaboration with Asian regulatory agencies was given. After the presentation, welcome remarks were given by Dr.Narong Aphkulvanich, Secretary General of Thai FDA and video greetings from Dr. Theresa Mullin, US FDA and Mr. Martin Harvey, EMA were shared. Acknowledgements were also given by Dr. SETO Yasuyuki, Director of NCCH, Dr. MIYAZAKI Hideyo, Director of NCGM and Dr. UENO Hiroaki, representative Director of JPMA.
H.E. Prof. TAKEMI Keizo, The Minister of Health, Labour and Welfare, Japan
Dr. FUJIWARA Yasuhiro, MD, Ph.D, PMDA, Japan (Presentation [827.74KB])
Dr. KITAHARA Jun, PMDA, Japan (Presentation [1.01MB])
Dr. Narong Aphikulvanich, Thai Food and Drug Administration
Dr. Theresa Mullin, U.S. Food and Drug Administration
Mr. Martin Harvey, European Medicines Agency
Dr. SETO Yasuyuki, MD, Ph.D, National Cancer Center Hospital, Japan (Presentation [1.57MB])
Dr. MIYAZAKI Hideyo MD, Ph.D, National Center for Global health and Medicine, Japan
Dr. UENO Hiroaki, Japan Pharmaceutical Manufacturers Association (Presentation [1.54MB])
Session 1
Under the moderation by Dr. KITAHARA and Dr. Azizah Ab Ghan, NPRA Malaysia, presentation and panel discussion were made in the theme entitled as “Changes in the Regulatory Environment Surrounding the Asian Region and Response -Collaboration with PMDA-”. At first, Mr. YASUDA Naoyuki, Associate Executive Director of PMDA, A/Prof. Cheng Leng Chan, HSA Singapore, and Ms. Worasuda Yoongthong Thai FDA made presentations regarding recent changes of regulatory environment, such as drug development environment including new modality products and post pandemic situation, and response to these changes. After the presentations, a panel discussion was conducted, including regulators from MoH Brunei Darussalam, MoH Lao P.D.R and NPRA Malaysia as panelists. The panelists discussed how to adapt to those recent changes of regulatory environment by collaborating among Asian regulators, and shared thoughts for PMDA’s role and expectation for the Asia Office.
Dr. KITAHARA Jun, PMDA, Japan
Dr. Azizah Ab Ghan, National Pharmaceutical Regulatory Agency, Malaysia
Mr. YASUDA Naoyuki, PMDA, Japan (Presentation [979.83KB])
A/Prof. Cheng Leng Chan, Health Sciences Authority, Singapore (Presentation [1.14MB])
Ms. Worasuda YOONGTHONG, Thai Food and Drug Administration (Presentation [260.95KB])
Ms. Siti Naasirah Hj Aji, Ministry of Health, Brunei Darussalam
Dr. Azizah Ab Ghan, National Pharmaceutical Regulatory Agency, Malaysia
Dr. Bounxou KEOHAVONG, Food and Drug Department, Ministry of Health, Lao P.D.R.
Session2
Under the moderation by Ms. ENDO Ayumi, Director of Office of Asia Training Center, PMDA and Ms. Jesusa Joyce N. Cirunay, FDA Philippines, presentation and panel discussion were made in the theme entitled as “Challenges for Capacity Building of Asian Regulatory Authorities - Utilization of PMDA Asia Training Center (PMDA-ATC) for the Asian Region –”. Ms. Jesusa Joyce N. Cirunay, FDA Philippines and Dr. Rita Endang, Apt, M.Kes, Indonesia FDA, presented their request and utilization of training activities provided by PMDA and their expectation to the training. Dr. KITAHARA presented training activities provided by PMDA. A panel discussion followed the presentations including regulators from MoH Cambodia, Indonesia FDA and Vietnam DAV as panelists. The panelists discussed utilization of PMDA-ATC training and expectation for the Asia Office.
Ms. ENDO Ayumi, PMDA, Japan
Ms. Jesusa Joyce N. Cirunay, Food and Drug Administration Philippines
Ms. Jesusa Joyce N. Cirunay, Food and Drug Administration Philippines
Dr. Rita Endang, Apt, M.Kes, Food and Drug Administration, Indonesia (Presentation [1.89MB])
Dr. KITAHARA Jun, PMDA, Japan (Presentation [1.10MB])
Ms. Nguyen Linh Chi, Drug Administration of Vietnam
Mrs.Chhay Roatheany, Drug and Food Ministry of Health, Cambodia
Mrs. Syamsidar Thamrin, Food and Drug Administration, Indonesia
Session3
Under the moderation by Dr. NAKAMURA Kenichi, National Cancer Center, and Dr. Virote Sriuranpong, Chulalongkorn University, presentations and panel discussion were made in the theme entitled as “Challenges for Capacity Building of Asian Regulatory Authorities - Utilization of PMDA-ATC for the Asian Region –”. Four presentations were delivered by Dr. TERADA Mitsutmi, National Cancer Center, Dr. Suvimol Niyomnaitham, Siriraj Hospital, Dr. Akhmal Yusof, Clinical Research Malaysia, and Dr TOKITA Daisuke, National Center for Global health and Medicine , introducing the activities to promote clinical trials and clinical trials network in Asian region. A panel discussion followed the presentations including academia research organizations from Japan, an industry representative from Japan and regulators from and Thai FDA and PMDA as panelists. The panelists gave opinions from their viewpoints.
Dr. NAKAMURA Kenichi, National Cancer Center, JAPAN
Dr. Virote Sriuranpong, Chulalongkorn University, Thailand
Dr. TERADA Mitsumi, National Cancer Center, Japan (Presentation [2.59MB])
Dr. Suvimol Niyomnaitham, Siriraj Hospital, Thailand (Presentation [3.22MB])
Dr. Akhmal Yusof, Clinical Research Malaysia, Malaysia (Presentation [3.97MB])
Dr. TOKITA Daisuke, National Center for Global health and Medicine, Japan (Presentation [2.10MB])
Mr. TOMOTSUGU Naoki, National Center for Global health and Medicine, Japan
Mr. NAKAJI Shigeru, Japan Pharmaceutical Manufacturers Association, Japan
Dr. KITAHARA Jun, PMDA, Japan
Ms. Akanid WAPEEWUTTIKORN, Thai Food and Drug Administration, Thailand
Closing
Dr. SATO Daisaku, Councilor for Pharmaceutical Affairs, MHLW concluded the symposium by emphasizing the importance of collaboration among the Asian regulatory authorities to address shared challenges and expressed hope that the Asia Office would serve as a central hub to facilitate this collaboration and improve healthcare in the region.
Contact Us
Division of Asia II, Office of International Programs, PMDA
TEL: +81-3-3506-9456
E-mail: PMDA-GD[at]pmda.go.jp
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