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March 26, 2007: U.S. AND JAPAN IMPLEMENT A PROGRAM TO SPEED MEDICAL DEVICE APPROVALS

When it comes to medical device approvals, the U.S. FDA and Japan's Pharmaceutical and Medical Devices Agency (PMDA) share similar scientific concerns and pose similar safety and effectiveness questions. In December 2003, a new pilot program called “Harmonization by Doing” (HBD) was launched with a goal of developing common protocols for clinical trials so that innovative medical devices can be available to patients more quickly.

The project is initially focused on cardiovascular technologies, specifically drug-eluting stents. However, the HBD program is expected to expand to include other cardiovascular devices and other device categories such as orthopedic products. As the HBD program matures, similar relationships with other regulatory bodies can also be developed in the future.

The HBD process is a cooperative effort to move both Japan and the U.S. toward international regulatory harmonization. However, instead of taking a theoretical approach to harmonization, HBD utilizes parallel development, application submissions and review of actual medical device projects by FDA’s Center for Devices and Radiological Health (CDRH) and the Japan’s Ministry of Health, Labor, and Welfare (MHLW) and its review agency PMDA.

The objective is to eliminate redundancies, added costs, and time delays inherent in sequential trials. The intent of HBD is not simply to create guidance and discuss policy but to develop common protocols for investigational clinical studies that would allow safe and effective “breakthrough” cardiovascular technologies to benefit patients worldwide.

Recently the HBD formed a steering committee and working groups. Current participants in the steering committee and working groups include FDA, MHLW, PMDA, industry trade associations and academia. The working groups hold shared meetings or “think tanks” that help develop and facilitate the HBD program. Attendance to the next Think Tank is open to the public. The next HBD Think Tank meeting is planned for 2008 in Japan.

If you are interested in participating in the Japan-US HBD Program, you can contact Shinichi Takae (Japan MHLW) takae-shinichi@mhlw.go.jp or Carole C. Carey (U.S. FDA) carole.carey@fda.hhs.gov

If you have comments regarding this update, please contact Romil Rambhia at 516-482-9001 or email at romil@mdiconsultants.com

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