MHLW has established, since 2016, a forerunner review system for specified devices, drugs and diagnostics. If designated, review periods are reduced by 8 months, and the post-marketing review is extended. The 7 cases designated as forerunners on February 28 comprise 3 medical devices, 1 in-vitro diagnostic and 3 regenerative medicines. The „forerunners“ are 1. boron neutron capture therapy (BNCT) by a research group of Kyoto University, Sumitomo Heavy Industries and Stella Pharma, for treatment of recurrent malignant glioma and unsresectable head and neck cancer, 2. and 3., a supercomputer-based cardiac simulation system developed by UT-Heart, a joint venture of The University of Tokyo and Fujifilm, for resynchronization therapy of the heart, 4. NCC Onco Panel, a genomics-based cancer gene diagnostic system co-developed by Sysmex and the Naitonal Cancer Research Center, 5. a doctor-led clinical trial on the treatment of Parkinson’s disease by iPS-derived dopamine neural progenitor cells, co-developed by CiRA and Dainippon Sumitomo Pharma, 6. the test of autologous oral-mucosa-derived esophageal cell sheets by Cellseed, and 7. bone-marrow derived pluripotent progenitor cells for patients in the acute phase of cerebral infaction, tested by Helios and introduced from Athersys Inc.