基于新《药物非临床研究质量管理规范》的毒性病理同行评议

Implementation of toxicologic pathology peer review based on the new edition of China Good Laboratory Practice

中国新的《药物非临床研究质量管理规范》已于2017年9月1日实施,该规范着重对病理同行评议做出明确的规定,鼓励和推荐开展病理同行评议,以提高病理诊断的准确性,提高病理报告的质量,对药物非临床研究有重要意义。本综述就该新规范关于毒性病理同行评议相关的内容进行了解读和详细说明,并提出了具体的实施方法,以期为行业人员提供参考。

The Chinese Food and Drug Administration issued the new Good Laboratory Practice（GLP）for nonclinical safety studies in September 2017,which emphasizes the peer review during the pathology practice. Pathology peer review could verify and improve the accuracy and quality of pathology diagnoses and interpretations in discussion. Pathology peer review is recommended when important risk assessment or business decisions are based on nonclinical studies. The objectives of this review are to provide a unified interpretation of the new regulation and recommend compliant processes for organizations to implement.