英国药品和健康产品局基于风险的 GCP 检查模式及对我国监管工作的启示

Introduction on and enlightenment from risk-based good clinical practices inspection model employed by Medicines and Healthcare Products Regulatory Agency

药物临床试验质量管理规范(GCP)检查是国家药品监管部门对药物临床试验进行监管的主要手段。有效地利用有限的监管资源在最大程度上确保药物临床试验相关各方对GCP的依从性,是各国药品监管部门在GCP检查工作中共同面临的挑战。英国药品和健康产品局在GCP检查方面进行了有益的尝试,实行基于风险的GCP检查模式。本文通过对英国GCP检查体系特别是基于风险GCP检查模式进行分析和探讨,对我国药物临床试验监管体系在检查范围的延展、信息共享平台的建立以及检查模式的改进方面提出建议。

Good clinical practice （ GCP） inspection is a primary tool for national drug regulatory authorities （ NRAs） in the world to regulate the drug clinical trials.How to take fullest advantage of strained inspection resources to ensure all the parties involved in clinical trials complying to GCP is the shared challenge for NRAs.Medicines and Healthcare Prod-ucts Regulatory Agency （ MHRA ） introduced the concept of “risk -based” to its GCP inspection system and made achievement.This paper explores MHRA ’ s GCP inspection system especially the risk -based GCP inspection model , and provides suggestions to improve GCP inspec-tion system in China.