PMDA-ATC GMP Inspection Seminar 2026
The PMDA-ATC GMP Inspection Seminar 2026 was held from September 15 to 17, 2026. Twenty-eight GMP inspectors from Bangladesh, Brazil, Cambodia, Egypt, India, Indonesia, Korea, Malaysia, the Philippines, Singapore, Taiwan and Thailand participated in the seminar.
The seminar opened with welcome remarks by Mr TAMIYA Kenichi, Senior Executive Director of PMDA, and Executive Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs (PMDA-ATC). Participants were also welcomed through a congratulatory video message from Ms Kathleen Sinninger, Chairperson of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S).
Opening / Closing Ceremonies
The seminar began with the theme, “Advanced Technologies in Pharmaceutical Manufacturing,” aligned with the theme of the PIC/S Seminar to be held later this year. Presentations from both regulators and industry representatives gave participants broad perspectives on approaches to assessing and inspecting advanced manufacturing technologies, including the application of artificial intelligence in pharmaceutical manufacturing.
On the second and third days, discussions focused on regulatory reliance, with particular attention to the Asian region. Results of a preliminary survey conducted among participants were presented and discussed as a basis for exploring practical approaches to strengthening regulatory cooperation. Experiences with regulatory reliance within the European Economic Area were also shared, providing participants with international perspectives. (program link [164KB])
Group Discussions
Seminar Speakers
The program concluded with an open discussion and a comprehensive wrap-up session. Participants reflected on all sessions, discussed challenges associated with advanced technologies and regulatory reliance, and shared their visions for future development in relevant areas. Throughout the seminar, six PMDA GMP inspectors facilitated discussions, sharing their expertise and practical experience.
At the closing session, Dr HARA Kentaro, Senior Coordinator of the seminar and Office Director of the Office of Manufacturing Quality for Drugs, congratulated the participants on successfully completing the program. Upon completion of the seminar, participants were awarded digital certificates.
The seminar also benefited from valuable contributions from external experts, including one lecturer from Japanese industry, five lecturers from overseas regulatory authorities, and six lecturers from overseas industry. PMDA would like to express its sincere appreciation to Swissmedic, Taiwan FDA, the Health Products Regulatory Authority (HPRA) of Ireland, the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), and the Japan Pharmaceutical Manufacturers Association (JPMA) for sharing their expertise and insights.
Comments from participants:
“Overall, the seminar was very well-organized, and the topics covered will be useful for GMP inspectors especially pertaining to AI and advanced manufacturing.”
“Enabling interactions between participants. Useful knowledge shared from industry and regulators.”
“I learned why regulatory reliance is important and how we can build and strengthen regulatory reliance in Asia. The session on advanced technologies was also very helpful in broadening my perspective on GMP.”
“I will conduct training sessions for our inspectors as Knowledge transfer”
“The knowledge we have obtained during this seminar will be immensely useful as the industries evolve to utilize AI in their daily operations.”
“Attending this seminar goes beyond just imagining what AI can do; it offers firsthand insight into how vendors have already developed AI solutions for visual inspection, HVAC systems, and quality management systems, while also providing valuable knowledge on audit techniques.”
Group Photo