本文選題：特殊審評 + 加速審評��； 參考：《中國新藥雜志》2017年22期

【摘要】：我國的藥品特殊審評體系經(jīng)過多年的發(fā)展取得了顯著進(jìn)展,但在審評質(zhì)量和效率上同發(fā)達(dá)國家仍存在較大差距。本文深入分析我國特殊審評體系存在的問題,基于對美國特殊審評體系和上市后臨床研究的經(jīng)驗(yàn)借鑒,提出完善多通道的特殊審評體系并建立特殊審評與上市后再評價(jià)的銜接的具體建議,以期提升審評效率,激發(fā)創(chuàng)新熱情。
[Abstract]:After years of development, China's special drug evaluation system has made remarkable progress, but there is still a big gap between China and the developed countries in the quality and efficiency of the evaluation. This paper deeply analyzes the problems existing in the special review system of our country, and draws lessons from the experience of the special review system in the United States and the post-market clinical research. In order to improve the efficiency of evaluation and stimulate the enthusiasm of innovation, the paper puts forward some concrete suggestions on how to perfect the special evaluation system of multi-channel and establish the link between special review and post-market re-evaluation.
【作者單位】： 中國藥科大學(xué)國家藥物政策與醫(yī)藥產(chǎn)業(yè)經(jīng)濟(jì)研究中心;
【基金】：國家社會科學(xué)基金重大項(xiàng)目——我國創(chuàng)新藥物政策環(huán)境研究(15ZDB167) 中央高�；究蒲袠I(yè)務(wù)費(fèi)項(xiàng)目(人文培育):藥品再評價(jià)法律制度研究(2016RPY003)
【分類號】：R95
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本文編號：1783779