June 2018: Japan Regulatory Updates

HBD has a workgroup focused on moving Japanese and U.S. clinical study sponsors and regulatory agencies toward the use of a single global clinical trial protocol for evaluating cardiovascular devices rather than parallel country-specific protocols. This would mean FDA may accept data from Japanese clinical studies using the joint protocols. Encouraging single global clinical trial protocols will facilitate device evaluation in both the U.S. and Japan by improving the timeliness and cost-effective generation of more informative clinical datasets for pre-market, and potentially post market evaluation. This will particularly benefit patients currently underserved by existing approved therapies.

HBD has a workgroup focused on standardizing information available in postmarket data registries, and reducing manufacturers’ premarket data requirements by using postmarket data. This workgroup developed and implemented the Japanese Registry for Mechanically Assisted Circulatory Support (J-MACS) registry, modeled after the U.S. Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) registry. These registries collect and analyze clinical and laboratory data from patients receiving mechanical circulatory support devices for end-stage heart failure. The complementary datasets in these registries provide valuable information for improving the treatment of advanced heart failure patients in both countries. The workgroup is developing an International Consortium of Cardiovascular Registries to bring together registry information from multiple countries.

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