PMDA-ATC Review of Cell therapy and Gene therapy products (CGTPs) Seminar 2025 for South-East Asian countries
The PMDA-ATC Review of Cell therapy and Gene therapy products Seminar 2025 for South-East Asian countries was organized July 15 to 17, 2025. It was attended by 25 participants from regulatory authority officials in South-East Asian countries, namely Brunei, Cambodia, Indonesia, Laos PDR, Malaysia, the Philippines, Singapore, and Thailand.
The seminar opened with welcome remarks from Dr. KONDO Emiko, Senior Executive Director of PMDA, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs, and Dr. MARUYAMA Yoshiaki, Senior coordinator of this seminar. Dr Maruyama also concluded the seminar.
Lectures covered topics including an overview of the review, quality control, non-clinical and clinical data review for CGTPs, and environment risk assessment. A Lecturer from industry shared perspectives on drug development in the field.
Participants engaged with the case studies on quality data and clinical data evaluation using materials derived from the actual reviews. During the roundtable discussion, participants presented the status of the CGTPs review in their respective countries and exchanged opinions. (program link [164KB])
A total of 17 lecturers and facilitators participated from industry and PMDA. Participants were awarded a digital certificate.
Photos and participant comments
Comments from the participants:
“I find the case studies interesting and so much I have learned from there.”
“This seminar helped me deepen my understanding on CGTPs and learned key points for consideration in reviewing CGTPs in my home country.”
“I will apply the knowledge from the seminar to develop CGTP guidelines on registration.”
“As we have on-going review of a CGTP application, this seminar helped me to see the bigger picture of the evaluation of CGTPs.”
