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Japan conditional early approval and time-limited approval 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. | none | none | law | ||
Sakigake designation (Japan) 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. | none | none | law |