APEC CoE Workshop: PMDA-ATC MRCT/GCP Inspection Seminar 2026
The PMDA organized a seminar on multi-regional clinical trials (MRCT) and good clinical practice (GCP) inspections for overseas regulators. Held in Tokyo, January 27 to 30, it served as a Center of Excellence (CoE) workshop as designated by the Asia Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (APEC‐RHSC). Twenty-eight participants from Bangladesh, Brazil, Chinese Taipei, Egypt, Indonesia, Kazakhstan, Malaysia, Pakistan, Peru, Philippines, Sri Lanka and Thailand participated.
The seminar opened with welcome remarks by Dr KONDO Emiko, Senior Executive Director of PMDA, and Director of PMDA-ATC, and Dr YANAGIHARA Reiko, Office Director, New Drug II, and Senior Coordinator of the seminar.
The program started with GCP inspection. A lecture on GCP inspection system in Japan was the first of sessions, followed by a GCP inspection case study with group discussion. Participants then shared snapshots of MRCT and GCP in their economies at a roundtable discussion. Day 2 started with a lecture on GCP inspections from the industry speaker and then the topic moved to MRCT.
It began with an introductive lecture on planning and designing of MRCT, followed by a case study. The third day started with a presentation by industry, on MRCT trends and decentralized clinical trials. A lecture on evaluating MRCT results was followed by a case study. Participants took up case studies in assigned groups, engaging in discussions and sharing group conclusions. The final day started with a lecture on MRCT operations by industry. The last session was led by the National Cancer Center Japan (NCCJ), a collaborator of this seminar. The lectures included GCP compliance at trial sites, clinical trials in China and in Asia. Joining PMDA specialists, lecturers and facilitators from NCCJ and Japan Pharmaceutical Manufacturers Association also shared their expertise and comments with participants. (see the program for details[155KB])
Dr Kondo and Dr Yanagihara also concluded the seminar. All successful participants were awarded a digital certificate of attendance.
Lecturers and facilitators
Leadership and discussions
Comments from participants:
“Great opportunity for gaining insight on GCP/MRCT in Japan and Asia. Case studies were very informative.”
“Challenging workshop, but very rewarding in terms of knowledge gained. Facilitators are knowledgeable and helpful.“
“I look forward to applying critical analyses methods when evaluating MRCT protocols.”
“Using guidelines and procedures discussed in the seminar, I will apply what I learned when reviewing clinical trial applications and assessing GCP inspection findings. This will help me make more consistent and evidence-based evaluations, improve the quality of my regulatory decisions.”
