MHLW designates several items for “forerunner review”
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 […]