新成份藥品 ( New Chemical Entity)
l 新劑型藥品 ( New dosage form)
l 新劑量藥品 ( New dose)
l 新使用途徑藥品 (New administration route )
l 新適應症藥品 (New indication)
l 學名藥 (Generic products )
l OTC 藥品 (OTC drug)
l 原料藥 (raw material of the pharmaceutical preparation)
1 新醫療器材/一般醫療器材與體外診斷試劑 – ( Class I, II and III of New / Conventional Medical devices and In Vitro Diagnostic reagent )
l 膠囊/錠劑食品(Food Supplements in Tablet /or Capsule form)
l 健康食品 ( Health food)
l 食品添加劑原料(raw material of food additives)
l 含藥化妝品 (Medicated cosmetic)、
l 變更登記 (例如包裝仿單變更/適應症變更/許可證移轉/產地變更) Re-registration (i.e. package mater |
看更多：
精選推薦
