發(fā)布時(shí)間：2018-04-21 19:22

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

【摘要】：我國(guó)的藥品特殊審評(píng)體系經(jīng)過(guò)多年的發(fā)展取得了顯著進(jìn)展,但在審評(píng)質(zhì)量和效率上同發(fā)達(dá)國(guó)家仍存在較大差距。本文深入分析我國(guó)特殊審評(píng)體系存在的問(wèn)題,基于對(duì)美國(guó)特殊審評(píng)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(píng)體系并建立特殊審評(píng)與上市后再評(píng)價(jià)的銜接的具體建議,以期提升審評(píng)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(guó)藥科大學(xué)國(guó)家藥物政策與醫(yī)藥產(chǎn)業(yè)經(jīng)濟(jì)研究中心;
【基金】：國(guó)家社會(huì)科學(xué)基金重大項(xiàng)目——我國(guó)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(píng)價(jià)法律制度研究(2016RPY003)
【分類(lèi)號(hào)】：R95
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本文編號(hào)：1783779