抄録
To obtain approval for new indications of existing drugs, companies usually need to conduct clinical trials to show the efficacy and safety for the indications. There exists a special scheme called "Kouchi-shinsei" (public knowledge-based application) in which companies can apply for approval without conducting additional clinical trials, if efficacy and safety for the new indication are recognized to be publicly known in the medical and pharmacological field through publications. Based on "Kouchi-shinsei", 170 compounds/116 indications have been approved. During the review process of these compounds/indications, active cooperation of academic societies and reinforcement of evidence by the regulatory authority were observed. In order that this scheme will be used effectively and continuously, further cooperations among pharmaceutical industry, regulatory authority, and academic societies are needed.
