病理學(xué)評估是藥物非臨床安全性評價的重要組成部分，也是確定和解釋毒理學(xué)研究結(jié)果的重要依據(jù)。病理學(xué)同行評議是確保病理學(xué)評估和病理學(xué)報告質(zhì)量的重要步驟。2019年7月，美國食品藥品監(jiān)督管理局（FDA）聯(lián)合其下屬6個中心編寫并頒布了《非臨床毒理學(xué)研究病理學(xué)同行評議指南草案》，以征求各界的意見或建議。美國毒性病理學(xué)會（STP）于2019年9月16日向美國FDA提交了電子版評論。就STP對FDA頒布的《非臨床毒理學(xué)研究病理學(xué)同行評議指南草案》所做的一般性評論、6個關(guān)鍵主題的主要評論及其他方面的補充評論進(jìn)行簡要闡述，以期為我國藥物非臨床安全性評價機構(gòu)更好地開展病理學(xué)同行評議提供一定參考。

Pathological assessment is an important part of non-clinical safety evaluation of drugs, and also an important basis for determining and interpreting toxicological results. Pathology peer review is an important step to ensure the quality of pathology assessments and pathology reports. In July 2019, Food and Drug Administration (FDA) of the U.S., in conjunction with six centers, prepared and issued the "draft guidance on pathology peer review in nonclinical toxicology studies" to ask for comments or suggestions. The Society of Toxicologic Pathology (STP) submitted comments electronically to the FDA on September 16, 2019. In this paper, the general comments, principal comments on six critical topics and other ancillary comments of STP on the "draft guidance for pathology peer review in non-clinical toxicology studies" are briefly introduced in order to provide references for better performing pathology peer review in the field of nonclinical safety evaluation of drugs in China.

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“十三五”重大新藥創(chuàng)制專項（2018ZX09201017）