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“Harmonization by Doing,” commonly known as HBD, is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals. This process is a cooperative effort to move both Japan and the U.S. toward international regulatory harmonization. Participants in this process include:

* U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH),
* Japan ’s Pharmaceutical and Food Safety Bureau (PFSB) of the Ministry of Health, Labour, and Welfare (MHLW) and its review agency, the Pharmaceutical and Medical Devices Agency (PMDA),


* Duke Clinical Research Institute (DCRI),
* Japanese academic community, and
* Japanese and U.S. medical device industry.

What is the HBD initiative?

The HBD initiative is a pilot project launched in December 2003 that seeks regulatory convergence between FDA and MHLW-PMDA premarket review of device cardiovascular technology. Instead of taking a theoretical approach to harmonization, HBD will utilize parallel development, application submissions and review of actual medical device projects by FDA and MHLW-PMDA in conjunction with the above-named constituencies. 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.

What are the benefits of HBD?

FDA and MHLW-PMDA share similar scientific concerns and reviewers pose similar safety and effectiveness questions. While there may be divergence in regulatory practices, the two agencies are willing to consider ways of approaching the differences in order to allow the availability of novel treatments and innovative, safe and effective medical devices to patients more quickly. Only through international collaboration can global market reviews be conducted in a timely manner. HBD should 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
* a new approach to early market availability of new treatment and devices to benefit patients in both countries
* a mechanism to decrease lag time between U.S. and Japanese product approval
* an atmosphere of international collaboration between regulators, regulated industry, clinical researchers, patients and academia
* a continuous progression in global harmonization

HBD concept is also a process that can be broadened in scope beyond premarket activities. It can also be applied to postmarket clinical studies, collection of postmarket data and patient registries.

For full information and links, go to
http://www.fda.gov/cdrh/international/hbdpilot.html