Historically, Japan has required, in its Good Clinical Practice ordinance, each clinical trial site to have its own IRB, which means each site director needs to ask for an IRB review separately. Unfortunately, this makes doing trials at multiple sites overly complicated. In response, the Health Sciences Council has blessed the MHLW’s desire to amend the GCP ordinance to make a single IRB responsible for multi-site trials. The proposed change would thus empower trial sponsors, rather than site directors, to request an IRB review. The proposed revision will take effect on April 1, 2026. The revision is expected to streamline the clinical trial process, reduce administrative burden, and accelerate study start-up timelines. These efforts are geared toward reducing Japan’s drug lag problem.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.