[IBENTO][IBENTO]Report of 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). 

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])

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.