組織病理學評估是非臨床毒理學試驗結果確定和解釋的重要環(huán)節(jié)，組織病理學同行評議可確保病理學診斷術語的一致性、準確性及病理診斷的完整性，還可以提高組織病理學評估的準確性和病理學報告的質(zhì)量。由于組織病理學同行評議過程需要考慮不同國家監(jiān)管機構的GLP法規(guī)要求，因此有必要對組織病理學同行評議的GLP符合性、流程、條件和注意事項等進行深入理解和總結，以促進我國組織病理學同行評議的計劃、管理、記錄和報告與國外發(fā)達國家達成一致。從開展組織病理學同行評議的目的及必要性、組織病理學同行評議的GLP原則、適用于組織病理學同行評議的GLP質(zhì)量體系、組織病理學同行評議的流程及條件以及組織病理學同行評議中的關鍵點進行闡述，以期為我國藥物非臨床安全性評價機構更好地開展組織病理學同行評議提供一定參考。

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.

國家"重大新藥創(chuàng)制"科技重大專項（2015ZX09501004-002）；創(chuàng)新藥物非臨床安全性評價研究關鍵技術（2018ZX09201017）