優先審查審查機制申請
優先審查審查機制申請 CDE 說明 https://www3.cde.org.tw/drugs/med_explain?id=24 CDE 英文版說明 https://www3.cde.org.tw/eng/drugs/med_explain?id=39 expedited programs The NDA standard review Expedited programs Review Time Key Qualifying criteria Standard Review 360 Days : NCE/ Biological Products 300 Days : Non-NCE with clinical efficacy and safety data 200 Days : Non-NCE without clinical efficacy and safety data 精簡審查 (Abbreviated Review) Category I :180 days Category II :120 days 2/3 approval (US FDA, EMA, or MHLW/PMDA) 3/3 approval (US FDA, EMA, or MHLW/PMDA) Unconditional approval of BSE waiver 優先審查 (Priority Review) 240 Days ( Two of the criteria shall be met) 1. New drug 2. Indication for serious condition and address an unmet medical need with major ...