“Harmonization by Doing” Program between the US and Japan

The US and Japan are currently working to expedite medical device approvals through the “Harmonization by Doing” (HBD) initiative. The HBD program was launched in December 2003, with its first meeting held in December 2005. A second meeting will take place in January 2007.

HBD was initially launched to focus on regulatory convergence between the FDA and Japan’s Ministry of Health, Labor and Welfare (MHLW) for cardiovascular-oriented medical device technology (specifically, drug-eluting stents). By developing common protocols for investigational clinical studies, HBD would utilize parallel development, application submission, and review of medical devices by both the FDA and the MHLW. By harmonizing clinical trial data so that it could be used in both the US and Japan, HBD would allow for shorter approval times. Though this initiative is currently limited to cardiovascular products, it could be expanded to include other fields such as orthopedics.

Establishing these guidelines would not only expedite medical device approvals, but also provide:

  • more robust clinical trials,
  • improved clinical research infrastructure,
  • better clinical trial data,
  • better understanding of how the U.S. and Japanese experience can complement one another,
  • and decreased time lag between U.S. and Japan product approval.

The FDA has also suggested that HBD could be applied not only to pre-market activities but also to postmarket clinical trials, and the collection of postmarket data and patient registries.

The HBD program currently holds shared meeting or “think tanks” which are open to the public to get feedback on the program. The next HBD think tank will take place on January 10-11, 2007 at Duke University in North Carolina.