{"slug":"jp","tag":"jp","variants":["jp"],"description":"No description yet","count":2,"kinds":{"term":2},"related":[{"slug":"law","tag":"law","shared":2}],"records":[{"id":"sakigake","kind":"term","name":"Sakigake designation (Japan)","route":"/terms/sakigake/","tldr":"Japan's fast lane for innovative medicines developed there first: a designated drug gets priority consultation, a six-month review instead of twelve, and a price premium, in return for early development in Japan."},{"id":"japan-conditional-early-approval","kind":"term","name":"Japan conditional early approval and time-limited approval","route":"/terms/japan-conditional-early-approval/","tldr":"Japan can approve a medicine for a serious disease on early data when a confirmatory trial would be hard to run, on condition that evidence is gathered after launch; for cell and tissue products a 2014 law allows a time-limited approval that must be confirmed within seven years."}]}