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No description yet: the sentence for this tag has not been written. 3 records carry it: 3 terms.
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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 | ||
Japan: Act on the Promotion of Cancer Registries (Act No. 111 of 2013) A 2013 Japanese law created a single national cancer registry: every hospital, and clinics designated by the prefecture, must report each newly diagnosed cancer, with its stage and treatment, to the prefectural governor. | 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 |