Japan’s health ministry will designate a new class of “international hub” hospitals for clinical trials starting in fiscal 2027, aiming to attract more trial business from overseas drugmakers. A subcommittee under the Ministry of Health, Labour and Welfare approved the qualifying criteria on August 27. Around four hospitals are expected to be chosen from existing core clinical research hospitals, though that number may grow gradually.
To qualify, hospitals must have held core status for at least five years, taken part in at least 50 industry-sponsored global trials over the past three years, and have English-speaking staff and investigators experienced in leading international trials. They will also need to handle inspections from regulators like the FDA and EMA, and offer English-language support for foreign sponsors.
The subcommittee also approved broader accreditation updates for all core clinical research hospitals. These include a new point-based system for scoring hospitals’ track records in investigator-led trials and clinical research. Hospitals will also be encouraged to pursue single institutional review boards and decentralized clinical trials.