define and clarify the rules for increased and better cooperation among all parties involved.(2)
Among the earliest undertakings of the HBD program was the SPIRIT III drug eluting stent clinical trial, a project initiated with Guidant Corporation in 2005. Guidant's participation through piloting the SPIRIT III trial enabled its product, XIENCETM V, an everolimus eluting coronary stent system, to be simultaneously evaluated in Japan and the US in the same clinical trial. This system replaced the separate sequential trials that have traditionally occurred in each country. The objective of this collaboration was to eliminate redundancies, added costs and time delays that typically occur in sequential trials. It is hoped that the parallel product development occurring between Japan and the US will permit the earlier introduction of medical device products to benefit patients in both countries.
In the more recent past, the HBD program has branched out to form a steering committee and working groups. Participants include the FDA, MHLW-PMDA, industry trade associations (Advanced Medical Technology Association and the Japanese Federation of Medical Device Associations), the DCRI and the Japanese academic community. The four proposed working groups will focus on global cardiovascular device trials (WG1); postmarket registries (WG2); clinical trials infrastructure and methodology (WG3); and, regulatory convergence and communication (WG4).(3) In spite of the FDA's and the MHLW-PMDA's divergent regulatory practices, the two agencies continue to explore ways of overcoming their different approaches to medical device development, investigation and approval. As the program matures, both agencies envision an expansion of the program to include other cardiovascular devices and device categories.
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