病理学同行评议在药物非临床安全性评价毒性病理学检查中具有重要地位，同行评议可以确定诊断术语的准确性和一致性、确定完整性、确定病理学报告内容的正确性，并可提高药物非临床毒理学研究的质量。2021年12月，美国食品药品监督管理局（FDA）颁布了《非临床毒理学研究病理学同行评议问答行业指南》。美国毒性病理学会（STP）科学和监管政策委员会（SRPC）工作组对FDA指南进行了深入分析和审阅，提供了评论和解释，并将多个国家和地区的毒性病理学会和美国质量保证学会（SQA）审阅该指南后，关于如何在遵循良好实验室规范（GLP）的非临床毒理学研究中管理、开展和记录病理学同行评议的建议进行了汇总。简要阐述STP的SRPC工作组对FDA《非临床毒理学研究病理学同行评议问答行业指南》9个问答的评论和建议，以期为我国药物非临床安全性评价机构更好地开展遵循GLP的病理学同行评议提供一定参考。

Pathology peer review holds significant importance in toxicologic pathology examination during nonclinical safety evaluation of drugs. Peer review is essential to determine accuracy and consistency of diagnostic nomenclature, determine completeness, and determine the correctness of textual interpretations of pathology report, thereby improving the quality of nonclinical toxicology studies of drugs. In december 2021, the United States Food and Drug Administration (FDA) issued the guidance for industry titled pathology peer review in nonclinical toxicology studies: Questions and answers. A working group commissioned by the Scientific and Regulatory Policy Committee (SRPC) of Society of Toxicologic Pathology (STP) conducted an in-depth review and analysis of the guidance, provided comment and interpretation, and summarized recommendations from many toxicologic pathology societies from different countries and regions as well as Society of Quality Assurance (SQA) on how to manage, conduct and document pathology peer review in nonclinical toxicology studies complied with Good Laboratory Practice (GLP) regulations. The comments and suggestions on all nine Q&A items in the FDA guidance by the working group of the STP were briefly reviewed, with a purpose to provide some references for facilities for nonclinical safety evaluation of drugs in China to better conduct pathology peer review complied with GLP regulations.

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2023年国家发改委基于AI的创新药物研发服务平台项目