隨著科學(xué)技術(shù)的發(fā)展，肝臟、腎臟、肺、心臟等單器官芯片模型及多器官芯片模型不斷出現(xiàn)，但如何準(zhǔn)確評(píng)價(jià)器官芯片的性能，推動(dòng)其向藥物研發(fā)及注冊(cè)監(jiān)管的應(yīng)用仍是當(dāng)前面臨的挑戰(zhàn)。為了能夠更好地了解器官芯片在藥物毒理學(xué)研究中應(yīng)用的法規(guī)要求，總結(jié)了國(guó)際上主要藥品監(jiān)管機(jī)構(gòu)開展的器官芯片認(rèn)證和驗(yàn)證工作的現(xiàn)狀，通過(guò)解讀國(guó)際專家共識(shí)并結(jié)合目前研究進(jìn)展，就器官芯片的監(jiān)管工作提出了幾點(diǎn)建議，以期為后續(xù)器官芯片在藥物安全性評(píng)價(jià)研究中的應(yīng)用提供參考。

Organ-on-chip(s) models of the liver, kidney, lung, heart and multiple organs have been developed as a result of the scientific technology revolution. To accelerate their application in drug development and medicine registration regulation, especially in toxicological research, guidance is needed in determining how to evaluate their performances precisely. To serve as a reference for subsequent drug safety evaluation, in this article, we first discussed the qualification and validation work of organ-on-chip(s) carried out by several major regulatory agencies in various countries. Then, several reasonable recommendations for organ-on-chip(s) validation by interpreting the expert consensus and the latest research progress were discussed.

國(guó)家“重大新藥創(chuàng)制”科技重大專項(xiàng)資助項(xiàng)目（2018ZX09201017-001，2018ZX09101002-002-002）