Division of Clinical Compliance Evaluation, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, United States (US) Food and Drug Administration (FDA), Silver Spring, MD, USA.
U.S. Food and Drug Administration, 10903 New Hampshire Ave, White Oak Building 51, Room 5370, Silver Spring, MD, 20993, USA.
Ther Innov Regul Sci. 2023 Jan;57(1):79-85. doi: 10.1007/s43441-022-00441-w. Epub 2022 Aug 16.
The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) began collaboration on Good Clinical Practice (GCP) inspections for marketing applications since 2009. The main characteristics of the GCP inspection processes between FDA and EMA were never evaluated. This is the first analysis comparing the GCP inspection processes between the two agencies.
We examined and analyzed the key characteristics of the GCP inspection processes, including the geographical distribution, inspection types and timelines from application submission to final inspection reporting for marketing applications from September 2009 through December 2015.
Fifty-five shared applications were included for analysis. For these applications, a total of 433 GCP inspections were conducted in 47 countries. Most clinical investigator (CI) inspections were conducted in regions outside of each agency's own regulatory jurisdiction, while most sponsor/contract research organization (CRO) inspections were conducted in the U.S. by both agencies. Twenty-eight shared applications included common sites inspected by both agencies. There were 15 joint inspections conducted for seven of these applications and the remaining applications had common sites inspected by both agencies at separate times. Of the joint inspections, 73% were conducted in the U.S and 20% in the E.U. The median time from submission of an application to generation of final inspection reports was 232 days for FDA and 204 days for EMA, with no significant differences noted among applications with and without common sites.
The inspection processes and timelines between the two agencies were similar, providing support for continued FDA-EMA GCP collaboration.
美国食品和药物管理局（FDA）和欧洲药品管理局（EMA）自 2009 年开始合作进行药品上市申请的良好临床规范（GCP）检查。FDA 和 EMA 之间 GCP 检查过程的主要特征从未进行过评估。这是首次分析比较这两个机构的 GCP 检查过程。
我们检查和分析了 GCP 检查过程的关键特征，包括自 2009 年 9 月至 2015 年 12 月申请提交至最终检查报告的地理分布、检查类型和时间线，涵盖了 55 个共享申请。
55 个共享申请被纳入分析。对于这些申请，共进行了 433 次 GCP 检查，分布在 47 个国家。大多数临床研究者（CI）检查在每个机构监管管辖范围之外的地区进行，而大多数申办方/合同研究组织（CRO）检查则由两个机构在美国进行。28 个共享申请包括由两个机构共同检查的共同地点。对于其中的 7 个申请进行了 15 次联合检查，其余申请则在不同时间由两个机构分别检查了共同地点。在联合检查中，73%在美国进行，20%在欧盟进行。对于没有共同地点的申请，从提交申请到生成最终检查报告的中位时间为 FDA 的 232 天和 EMA 的 204 天，两者之间没有显著差异。
两个机构的检查过程和时间线相似，为继续进行 FDA-EMA GCP 合作提供了支持。
