PMDA-ATC GMP Inspection Seminar 2025
The PMDA-ATC GMP Inspection Seminar 2025 was organized September 17 to 19, 2025. Designed for GMP Inspectors, it was attended by 28 participants from Cambodia, Chinese Taipei, Egypt, Hong Kong (SAR), India, Indonesia, Kazakhstan, Laos, Malaysia, Pakistan, Philippines, Singapore, Thailand and Uzbekistan.
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. It was followed by a congratulatory video message from Mr. Jacques Morenas, Chairperson of PIC/S.
The themes of this seminar, “Advanced Technologies” was set in alignment with the PIC/S seminar this year. The theme of PIC/S seminar is “Advanced Technologies in pharmaceutical manufacturing”. Lectures covered introduction of smart manufacturing with advanced technologies, and the challenges faced, from respective perspectives of industry, PMDA and WHO. The lead of drafting PIC/S guidelines shared revised annex 11 - Computerized Systems and new annex 22 - Artificial Intelligence. Results from the preliminary survey about the status and actions in advanced technology at participant countries were shared, then following discussions, it was confirmed that the keys for future GMP inspection are harmonization and deep understanding of the guidelines for the introduction of advanced technologies.
Lectures of the other theme “Regulatory Reliance” included pathways to realize reliance as envisioned by PMDA and the results from the preliminary survey about reliance from participants. Through the session, it was shared that Regulatory Reliance can reduce duplicate inspections, make global oversight more efficient whilst ensuring good quality and stable supply of pharmaceuticals. A panel discussion on GMP Inspection Reliance was held with all participants and the panelists invited from Asian regulatory authorities.
The program also included an open discussion, a recap of all sessions, the challenges, and goal image for “Advanced Technology” and “Regulatory Reliance” as the wrap-up.(program link [115KB])
Seven lecturers and panelists from PMDA and 1 lecturer from Japanese industry participated. In addition, 7 global lecturers and panelists kindly participated from Asian regulatory authorities of Chinese Taipei (TFDA), Singapore (HSA) and South Korea (MFDS), as well as Denmark (DKMA) and WHO. Participants were awarded a digital certificate.
Photos and participant comments
Comments from the participants:
“The seminar was highly informative and well organized. The topics were relevant and timely with emerging need of AI regulation guidelines. The speakers demonstrated deep expertise, and their presentations engaging and insightful.”
“Good interactive sessions, well facilitated and great information exchanges on best practices, current situations and developments in various countries.
“Seminar may include actual case studies visiting a company with AI based pharma systems in the future.”
“We can all better understand advanced technologies and apply these insights in our daily work, helping us stay aligned with current regulatory practices.”
