ACCSQ PPWG - PMDA-ATC Pharmaceuticals Review Seminar 2025
PMDA-ATC organized a pharmaceuticals review seminar for ASEAN member states. It was held in Tokyo, October 7 to 10 for participants from Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Thailand and Viet Nam. The 27 attendees represented Pharmaceutical Product WG (PPWG) members of the ASEAN Consultative Committee for Standards and Quality (ACCSQ).
The seminar was designed as part of the PMDA-ATC initiative to promote ASEAN joint assessment and bilateral reliance schemes, to improve participants’ data evaluation skills, comprising practical case studies. Opening with new drug reviews in Japan, lectures covered new drugs evaluation considerations, the PMDA review report, and risk management plans. Participants worked in groups on five case studies, on quality, pharmacology, toxicology, ADME and clinical data. Each country shared the implementation status and issues of the ASEAN joint assessment in their countries, to which two specialists from WHO joined online and engaged with the presenters. A total of 25 PMDA specialists shared their experiences as lecturers and facilitators. Two observers from ASEAN secretariat were also welcomed to the seminar.
see the program for details [153KB]
The seminar opened with welcome remarks from Dr. KONDO Emiko, Senior Executive Director of PMDA and Director of PMDA-ATC, and Dr YANAGIHARA Reiko, the Senior Coordinator of the seminar. Drs Kondo and Yanagihara also concluded the seminar. All successful attendees were awarded a digital certificate of attendance.
PMDA-ATC will continue to organize more seminars not only in Japan but also overseas, working with colleagues towards harmonization and high standards in regulations in Asia and the region. A particular focal point is our collaboration with ASEAN members.
PMDA lecturers and WHO panelists
ATC leadership at opening/closing ceremonies, participants at the venue
Comments from the participants:
“This seminar was both insightful and well-executed. It provided valuable knowledge, fostered meaningful discussions and strengthened collaboration among ASEAN member states, benefiting both participating individuals and the authorities”
“The seminar offered in-depth training on Japan's new drug evaluation process. Using real examples in case studies, the session enhances scientific data evaluation skills”
“The lecturer encourages me to think step by step and makes learning everything he teaches really fun”
