【摘要】：本文從我國(guó)新藥優(yōu)先審評(píng)模式的前身——特殊審批制度出發(fā),通過(guò)構(gòu)建評(píng)價(jià)指標(biāo)體系,回顧特殊審批制度實(shí)施績(jī)效,并在借鑒國(guó)外優(yōu)先審評(píng)模式的基礎(chǔ)上,結(jié)合我國(guó)國(guó)情和藥品審評(píng)審批改革目標(biāo),提出優(yōu)先審評(píng)模式的完善建議。建議從適用范圍分類(lèi)細(xì)化、加速審評(píng)時(shí)間節(jié)點(diǎn)設(shè)置、審評(píng)團(tuán)隊(duì)建設(shè)三方面優(yōu)化優(yōu)先審評(píng)模式。
[Abstract]:Based on the special examination and approval system, which is the predecessor of the new drug priority review model in China, this paper reviews the performance of the special examination and approval system through the construction of the evaluation index system, and on the basis of drawing lessons from the foreign priority review model, According to the situation of our country and the target of drug review and approval reform, the paper puts forward some suggestions on how to perfect the mode of priority review. It is suggested that the priority review mode should be optimized from three aspects: the classification of the applicable scope, the acceleration of the setting of the review time node and the construction of the review team.
【作者單位】： 中國(guó)藥科大學(xué);國(guó)家食品藥品監(jiān)督管理總局藥品審評(píng)中心;
【分類(lèi)號(hào)】：R95

【相似文獻(xiàn)】

相關(guān)期刊論文 前1條

1 袁泉;邵蓉;;基本藥物可獲得性障礙研究[J];上海醫(yī)藥;2010年03期

，

本文編號(hào)：2164031