Japan’s health ministry is urging pharmaceutical companies to choose institutional review boards (IRBs) carefully, as the country prepares to overhaul its Good Clinical Practice rules. The forthcoming revision, due to be promulgated this summer, will allow trial sponsors to directly select a single IRB to cover multiple clinical trial sites. This replaces the current system where each institution runs its own IRB. The ministry acknowledged the change raises integrity concerns, particularly around sponsors cherry-picking favorable IRBs or conflicts of interest skewing reviews. To prevent this, companies will be required to document their IRB selection rationale, and IRBs themselves will need to publicly disclose member rosters and meeting records.
Japan and Malaysia have signed a Memorandum of Cooperation (MOC) on medical device regulation, formalized in Tokyo on June 8, 2026. The agreement commits Japan’s MHLW and Malaysia’s MDA to closer collaboration across several areas, including scientific cooperation, human resource training, and multilateral forum engagement. Working groups may be established with participation from industry and academia, offering the private sector a potential role in shaping regulatory dialogue. For medical device companies active in Asia-Pacific, the deal signals a long-term push toward greater regulatory alignment between two significant markets. The MOC runs for five years and renews automatically unless either party opts out.
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.