Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5324, Silver Spring, MD, 20993, USA.
Inspections Office, Quality and Safety of Medicines Department, European Medicines Agency (EMA), Domenico Scarlattilaan 6, 1083 HS, Amsterdam, The Netherlands.
Ther Innov Regul Sci. 2022 Sep;56(5):753-764. doi: 10.1007/s43441-022-00417-w. Epub 2022 May 24.
The United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) have collaborated in good clinical practice (GCP) inspections since September 2009. The two agencies operate under different regulatory frameworks for GCP oversight. No systematic assessments of GCP inspection findings have been reported.
We identified common inspections of clinical investigators, sponsors, and contract research organizations conducted by both agencies in support of marketing applications that had the same trial data submitted between 2009 and 2015. We grouped inspection findings into deficiency areas. We reviewed and compared these findings and calculated concordance rate for each deficiency area.
Twenty-six clinical investigator sites and 23 sponsors/contract research organizations were inspected by both agencies in support of 31 marketing applications during this period. For FDA, the most common GCP findings were deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management issues for sponsor/contract research organization inspections. For EMA, deficiencies related to Documentation (including Trial Master File) were the most common findings for both clinical investigator and sponsor/contract research organization inspections. There was high concordance, of approximately 90%, for deficiencies related to Protocol Compliance for clinical investigator inspections and Trial Management for sponsor/contract research organization inspections between the two agencies. There was a concordance rate of about 70% for Documentation deficiencies for both clinical investigator and sponsor/contract research organization GCP inspections.
GCP inspection findings from 49 common clinical investigator and sponsor/contract research organization inspections were comparable, providing support for continued FDA-EMA GCP collaboration.
自 2009 年 9 月以来，美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）一直在良好临床规范（GCP）检查方面进行合作。这两个机构在 GCP 监督方面的监管框架不同。目前尚未报告对 GCP 检查结果进行的系统评估。
我们确定了这两个机构共同对临床研究者、申办者和合同研究组织进行的常见检查，这些检查是为了支持在 2009 年至 2015 年间提交相同试验数据的营销申请。我们将检查结果分为缺陷领域。我们审查并比较了这些结果，并计算了每个缺陷领域的一致性率。
在此期间，这两个机构共检查了 26 个临床研究者场所和 23 个申办者/合同研究组织，以支持 31 个营销申请。对于 FDA，最常见的 GCP 发现是临床研究者检查中与方案遵守有关的缺陷和申办者/合同研究组织检查中的试验管理问题。对于 EMA，临床研究者和申办者/合同研究组织检查中最常见的缺陷是与文件（包括试验主文件）有关的缺陷。两个机构之间，临床研究者检查中与方案遵守有关的缺陷和申办者/合同研究组织检查中的试验管理问题的一致性约为 90%。对于临床研究者和申办者/合同研究组织 GCP 检查中的文件缺陷，一致性率约为 70%。
49 次共同的临床研究者和申办者/合同研究组织检查的 GCP 检查结果具有可比性，为继续进行 FDA-EMA GCP 合作提供了支持。
