Implementation of toxicologic pathology peer review based on the new edition of China Good Laboratory Practice / 国际药学研究杂志

ABSTRACT

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 im?prove 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.