Japan Specifies Quasi Drug Manufacturing and Sale Certificate Application Documentation Requirements

In Japan, application for a quasi-drug manufacturing and sale certificate (hereinafter referred to as "certificate") requires provision of a product safety report and product efficacy report. Japan MHLW recently specified the requirements related to generation of clinical evaluation data for these reports.

Products defined as quasi-drugs and applied to face, lips and whole skins (repeatedly used) require the safety report and efficacy report collecting data from clinical evaluations. Specifically, the data include results from three human-related trials: human patch test, long-term human safety test and efficacy or effect test.