1st Clinical Trial and GCP Workshop
1st Clinical Trial and GCP Workshop was jointly organized by the PMDA-ATC and Clinical Research Malaysia (CRM) on May 6, 2026. Designed for strengthening clinical trial regulatory functions and GCP inspection capabilities, it was attended by 18 GCP inspectors from Malaysia, Thailand, Indonesia and the Philippines. The workshop was held as a pre-conference event of the CRM Trial Connect 2026 in Kuala Lumpur.
The Clinical Trial and GCP Workshop aims to share and discuss regulatory experiences, practical challenges, and initiatives among participating authorities. The workshop is designed for a three-year program with fixed members.
The primary objectives of the 1st Clinical Trial and GCP Workshop was to enhance mutual understanding of the current status of GCP inspections in each participating country and establish a foundation for future discussions on practical challenges.
Following opening remarks by Dr. Shinichi NODA, Head of the Asia Office, PMDA staff member and GCP inspector shared an overview of the regulatory framework for clinical trials and GCP inspections in Japan. Subsequently, participants shared information on the current status of their GCP inspections, including the number of inspections conducted, organizational structures, and approaches to guidance and corrective actions, followed by further discussion. In addition, PMDA GCP inspector presented its latest initiatives to improve the clinical trial environment in Japan, and CRM staff member introduced its efforts in the training of clinical research coordinators. To conclude the workshop, participants shared their 12-month goals, discussed potential initiatives to be advanced through the workshop, and explored the future evolution of this collaboration.
Comments from participants:
- The workshop was an excellent avenue for GCP inspectors to exchange ideas and innovative solutions regarding GCP inspections. I hope to meet GCP inspectors from other countries, not just within ASEAN, so that we can learn international best practices in GCP inspections.
Aside from that, I learned so much from the workshop and am looking forward to the next one. - The workshop was a great platform for meeting, sharing, and exchanging information among the ASEAN member states’ NRAs and the PMDA.
