【正文】
交簡(jiǎn)要文檔的進(jìn)口藥品,申請(qǐng)方需提供臨床研究綜述、研究研究總結(jié)報(bào)告、所有臨床研究列表、主要或相關(guān)臨床研究的研究報(bào)告(不需附件)和主要參考文獻(xiàn)清單。參考文獻(xiàn):(所有的參考文獻(xiàn)都是新加坡衛(wèi)生科學(xué)局網(wǎng)站上下載:)1. Guide for Approval to Import Medicinal Products For Reexport Sep04_Biopolis Update2. Import Licence_NA_Guide_Sep04_Biopolis Update3.Guidance For Drug Registration In Singapore_Effective 1 Nov 2004 4.Regulatory approaches in sg 5.Drug Registration System Overview_01Oct04 6.Guidelines for Reclassification of Human Medicines Sep04_Biopolis Info Update 7.ACTD Nonclinical data 8.ACTD Clinical 9.Glossary used inACTD and ACTR_Jan0510.Guide for Approval to mport Unregistered Medicinal Products Sep04_Biopolis Update