APEC CoE Workshop: PMDA-ATC MRCT/GCP Inspection Seminar 2025
The PMDA held the “APEC Center of Excellence Workshop: PMDA-ATC MRCT/GCP Inspection Seminar 2025“ from January 21 to 24. This seminar served as the Center of Excellence (CoE) workshop for the Multi‐Regional Clinical Trials (MRCT) and Good Clinical Practice (GCP) inspection designated by the Asia Pacific Economic Cooperation, Regulatory Harmonization Steering Committee (APEC‐RHSC). This seminar was intended for officials of overseas regulatory agencies. It was attended by 30 participants from Bangladesh, Brazil, Chinese Taipei, Cuba, Egypt, Hong Kong China, Indonesia, Malaysia, Pakistan, Peru, the Philippines, Saudi Arabia, Thailand, and Uzbekistan.
The seminar opened with the remarks by Dr. KONDO Emiko, Senior Executive Director of PMDA, Director of the Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs., followed by Dr. NAKAMURA Ryuta, Office Director of Office of New Drug I and Senior coordinator of this seminar.
On the first day, lectures on GCP inspection in Japan from the perspective of the PMDA and industry were given, followed by a case study on GCP inspection. During the roundtable discussion, representatives gave presentations on clinical trials and MRCT operations in each economy. The second day included a lecture and a case study on “points to consider when planning and designing MRCT,” while the third day covered “points to consider when evaluating MRCT results” after a lecture on “Current MRCT status and Decentralized Clinical Trial” by industry. Participants engaged in intensive discussions in groups and presented the results of each case study. On the final day, a lecture on “MRCT operation” by industry and lectures on “clinical trial operation,” “GCP compliance” as well as “clinical trial network in Asia” by the National Cancer Center (NCC) were provided. In this seminar, the PMDA, NCC, and Japan Pharmaceutical Manufacturers Association shared their expert knowledge and comments with participants as lecturers or facilitators, which contributed to this meaningful seminar. (See the program for details[155KB])
This event was closed with the speech from Dr. KONDO Emiko, followed by the speech from Dr. NAKAMURA Ryuta. As a token of active participation in the seminar, the digital certification of Open Badge was given to the participants.
Photos and participant comments
Comments from the participants:
"It was a good way to understand how PMDA and Japan deal with MRCT and GCP inspection. And it was a great opportunity to exchange experience with other countries."
"The seminar was very informative and knowledgeably especially the practical part."
"Well structured. Great to have GCP inspectors and reviewers speak to us."
"The topics covered were relevant and provided practical knowledge that can be applied in daily work."
"I feel very thankful to know the detail of the new trend and the industrial aspect to the clinical trial."
"I will try to apply remote inspection and electronic informed consent process in my country, and put the additional standards to validate and make sure of appropriate compliance to GCP principles."
"I will try to get it done and trained rest of the officers to strengthen their skills and knowledge."
"My learnings from MRCT and GCP is vital to my current work as Safety and Efficacy evaluator. I will apply my knowledge from this seminar to my evaluations and also share and cascade to my colleagues."
