On March 1, the Japanese cabinet issued a draft bill which creates an emergency approval system for devices and drugs. The draft will make it easier for these medical products to receive approvals based on presumed efficacy if there is an emergency. For such products, there will be increased leniency with respect to notifications, labeling, GMP requirements, etc. Products with emergency approvals would only be allowed for a maximum of 2 years. Despite this quick process in Japan, these products eventually will need to confirm safety similar to other products being evaluated. The draft is now awaiting final approval.
