組織病理學(xué)評(píng)估是非臨床毒理學(xué)試驗(yàn)結(jié)果確定和解釋的重要環(huán)節(jié)，組織病理學(xué)同行評(píng)議可確保病理學(xué)診斷術(shù)語(yǔ)的一致性、準(zhǔn)確性及病理診斷的完整性，還可以提高組織病理學(xué)評(píng)估的準(zhǔn)確性和病理學(xué)報(bào)告的質(zhì)量。由于組織病理學(xué)同行評(píng)議過(guò)程需要考慮不同國(guó)家監(jiān)管機(jī)構(gòu)的GLP法規(guī)要求，因此有必要對(duì)組織病理學(xué)同行評(píng)議的GLP符合性、流程、條件和注意事項(xiàng)等進(jìn)行深入理解和總結(jié)，以促進(jìn)我國(guó)組織病理學(xué)同行評(píng)議的計(jì)劃、管理、記錄和報(bào)告與國(guó)外發(fā)達(dá)國(guó)家達(dá)成一致。從開(kāi)展組織病理學(xué)同行評(píng)議的目的及必要性、組織病理學(xué)同行評(píng)議的GLP原則、適用于組織病理學(xué)同行評(píng)議的GLP質(zhì)量體系、組織病理學(xué)同行評(píng)議的流程及條件以及組織病理學(xué)同行評(píng)議中的關(guān)鍵點(diǎn)進(jìn)行闡述，以期為我國(guó)藥物非臨床安全性評(píng)價(jià)機(jī)構(gòu)更好地開(kāi)展組織病理學(xué)同行評(píng)議提供一定參考。

Histopathology assessment is an important step for the determination and interpretation of the results of nonclinical toxicology studies. Histopathology peer review can ensure the consistency, accuracy of pathological diagnosis terms and the completeness of pathological diagnosis, and can improve accuracy of histopathology assessment and the quality of pathology reports. Because the histopathology peer review processes need to be considered the requirements of the GLP regulations of different countries, therefore, it is necessary to deeply understand and summarize the GLP compliance, processes, conditions and considerations of histopathology peer review so as to promote the consistency in planning, conducting, documenting and reporting of the histopathology peer review in China with developed countries abroad as soon as possible. This article introduced the purpose and necessity of carrying out the histopathology peer review, the GLP principles of histopathology peer review, the GLP quality system applicable to the histopathology peer review, the processes and conditions of histopathology peer review, as well as the key points for the histopathology peer review, with the purpose of providing some references for better carrying out histopathology peer review in nonclinical safety evaluation facilities for drugs in China.

國(guó)家"重大新藥創(chuàng)制"科技重大專(zhuān)項(xiàng)（2015ZX09501004-002）；創(chuàng)新藥物非臨床安全性評(píng)價(jià)研究關(guān)鍵技術(shù)（2018ZX09201017）