LEXICON
No.15
October 18, 2010
“Application based on data from the public domain”or “public knowledge-based application”公知申請
“Application based on data from the public domain”or “public knowledge-based application”
公知申請
As a rule, applicants for new drugs and indications in Japan are required to conduct clinical trials in Japan to confirm their efficacy and safety in ethnic Japanese patients. If there is solid evidence of efficacy and safety, however, clinical...
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