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The EMA GCP Inspectors Working Group Annual Report 2023 provides a comprehensive overview of GCP compliance across global clinical research. It highlights 67 site inspections, revealing 720 deficiencies, with nearly half categorized as major. Key issues include sponsor oversight, protocol adherence, IMP handling, and informed consent processes. The report emphasizes the need for strengthened regulatory compliance, robust site management, and the growing role of technology in clinical research. It serves as a reminder for sponsors, CROs, and investigators to continue investing in training, systems, and proactive measures to address deficiencies.
EMA GCP 检查员工作组 2023 年年度报告全面概述了全球临床研究中的 GCP 合规情况。报告提到 67 次现场检查，共发现 720 项缺陷，其中近一半为主要缺陷。关键问题包括申办方监督、方案遵守、研究药物处理和知情同意流程。报告强调加强法规合规性、完善中心管理以及技术在临床研究中日益重要的作用。它提醒申办方、CRO 和研究者需要持续投资培训和系统及主动措施以解决缺陷。
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EMA GCP Inspectors Working Group
Annual Report 2023
EMA GCP 检查员工作组 2023 年年度报告
The European Medicines Agency’s (EMA) recently published Good Clinical Practice (GCP) Inspectors Working Group Annual Report for 2023 provides valuable insights into the state of GCP compliance across clinical research globally. Here are the key takeaways from the report, highlighting trends and areas of focus for clinical trial sponsors, investigators, and other stakeholders.
欧洲药品管理局（EMA）发布的《2023 年 GCP 检查员工作组年度报告》提供有关全球临床研究 GCP 合规状态的宝贵洞见。以下是报告的重点解读，关注在临床试验申办方、研究者和其他利益相关方需要注意的趋势和焦点领域。
GCP Site Inspections in 2023
2023 年 GCP 现场检查
In 2023, the Committee for Medicinal Products for Human Use (CHMP) requested 67 GCP site inspections, including 58 routine inspections and 9 triggered inspections, conducted by inspectorates across the EU/EEA Member States (MSs). These inspections spanned multiple regions:
2023 年，欧盟人用药品委员会（CHMP）要求进行 67 次 GCP 现场检查，包括 58 次例行检查和 9 次触发检查，由欧盟/欧洲经济区（EU/EEA）成员国的检查机构执行。这些检查覆盖了多个地区：
- EU/EEA: 34.3% of inspections
欧盟/欧洲经济区：34.3% 的检查
- Asia: 28.4% of inspections
亚洲：28.4% 的检查
- North America: 17.9% of inspections
北美洲：17.9% 的检查
These figures underline the global nature of clinical trials and the growing importance of regulatory oversight in non-EU/EEA regions, especially Asia, where a significant portion of trials are now conducted.
这些数据强调了临床试验的全球化特性，以及在非欧盟/欧洲经济区地区（尤其是亚洲）加强监管的重要性，因为该地区的试验占比显著增加。
Inspection Findings and Deficiency Trends
检查结果和缺陷趋势
The inspections revealed a total of 720 deficiencies, averaging 11 findings per inspected site, categorized as follows:
检查共发现 720 项缺陷，每个检查平均发现 11 项问题，具体分类如下：
Critical findings: 36 (5.0%)
严重缺陷：36 项（5.0%）
Major findings: 336 (46.7%)
主要缺陷：336 项（46.7%）
Minor findings: 348 (48.3%)
次要缺陷：348 项（48.3%）
This distribution demonstrates that while most deficiencies were not critical, almost half were categorized as major, reflecting substantial issues with compliance that could impact trial validity or participant safety.
这些数据表明，尽管大多数缺陷并非严重，但几乎一半被归类为主要缺陷，反映了合规性方面存在的重大问题，这些问题可能影响试验的有效性或受试者的安全性。
Key Categories of Findings
发现的关键问题类别
The deficiencies were observed across a range of categories, pointing to persistent challenges in clinical trial conduct and management:
这些缺陷分布于多个类别，反映出临床试验实施和管理中的持续性挑战：
- General: Broad issues affecting overall compliance.
一般问题：影响整体合规性的广泛问题。
- Trial Management (Sponsor): Concerns with sponsor oversight, documentation, and coordination.
试验管理（申办方）：与申办方监督、文件管理和协调相关的问题。
- Investigational Site: Site-level issues, including adherence to protocol and investigator responsibilities.
研究中心：中心层面的问题，包括遵守方案和研究者职责。
- Investigational Medicinal Products (IMPs): Handling, storage, and documentation of IMPs.
研究药物（IMPs）：IMP 的处理、存储和文件记录。
- Computer Systems: Issues with electronic data management and validation.
计算机系统：电子数据管理和验证问题。
- Laboratory/Technical Facilities: Problems with testing facilities and equipment.
实验室/技术设施：检测设施和设备的问题。
- Informed Consent: Deficiencies in obtaining and documenting participant consent.
知情同意：获取和记录受试者同意的缺陷。
- Participant Protection: Issues affecting the safety and rights of trial participants.
受试者保护：影响受试者安全和权利的问题。
- Independent Ethics Committee (IEC)/Institutional Review Board (IRB): Gaps in ethical oversight.
独立伦理委员会（IEC）/机构审查委员会（IRB）：伦理监督的不足。
- Regulatory Issues: Non-compliance with applicable regulations.
监管问题：未遵守相关法规的情况。
These findings emphasize the need for strengthened sponsor oversight, robust site management, and meticulous regulatory compliance to maintain the integrity of clinical trials.
这些发现强调了加强申办方监督、完善中心管理以及细致遵守法规的重要性，以维护临床试验的完整性。
Implications for the Clinical Research
对临床研究的意义
The 2023 GCP inspection findings offer several critical lessons for the industry:
2023 年 GCP 检查结果为行业提供了几个重要的启示：
Global Focus: The increased proportion of inspections outside the EU/EEA highlights the importance of ensuring global sites meet the same rigorous standards as those in the EU/EEA.
全球视角：非欧盟/欧洲经济区检查比例的增加强调了确保全球试验中心符合同等严格标准的重要性。
Major Deficiencies: With nearly half of the findings categorized as major, sponsors and investigators must prioritize resolving systemic issues in trial management, participant protection, and IMP handling.
主要缺陷：近一半的问题被归类为主要缺陷，申办方和研究者必须优先解决试验管理、受试者保护和IMP处理中的系统性问题。
Emerging Trends: Categories like computer systems and laboratory facilities underscore the growing role of technology and the need for validated, compliant systems in clinical research.
新兴趋势：计算机系统和实验室设施等类别突出了技术的重要性以及临床研究中验证和合规系统的需求。
Conclusion
结论
The EMA GCP Inspectors Working Group Annual Report serves as a critical reminder of the importance of GCP compliance in safeguarding trial participants and ensuring the integrity of clinical research. For sponsors, CROs, and investigators, these findings highlight the need for ongoing vigilance, continuous training, and robust systems to address deficiencies proactively.
EMA GCP 检查员工作组年度报告提醒我们GCP 合规对于保护试验受试者和确保临床研究的完整性至关重要。对于申办方、CRO 和研究者而言，这些发现强调持续保持警惕、持续培训、以及建立健全系统以主动解决缺陷的必要性。
Why Choose Widler & Schiemann Ltd.
选择卫森医药咨询的原因
WS Consultants Expertise: Our consultants bring over 20 years of experience from leading pharmaceutical and facing regulatory inspections, we specialize in helping organizations navigate the complex FDA inspection process.
WS顾问的专业知识：我们的顾问拥有来自领先制药和应对监管检查超过20年的经验，我们专注于帮助企业应对复杂的FDA/EMA检查流程。
Our end-to-end services, from initial preparation to ongoing support, ensure that you are always inspection-ready.
我们的检查准备全过程顾问服务，从初期准备到持续支持，确保您始终准备就绪。
We provide long-term support, ensuring your inspection readiness process is always aligned with the latest industry standards and regulatory requirements.
我们提供长期支持，确保检查准备流程始终符合最新的行业标准和监管要求。
If you're preparing for a regulatory inspection, expanding into new markets, or seeking to enhance operational efficiency, our Inspection Readiness services are your trusted solution. Contact us today to learn how Widler & Schiemann Ltd. can help your organization achieve quality and compliance excellence.
若您准备迎接监管检查、拓展新市场、或寻求提高运营效率，我们的检查准备服务都是您值得信赖的解决方案。欢迎联系我们，进一步了解卫森医药咨询（上海）有限公司如何帮助您的组织实现卓越质量合规。
We look forward to working side by side with your team to deliver quality, compliance, and successful FDA/EMA inspection.
我们期待与您的团队并肩合作，达成质量合规，顺利完成FDA/EMA检查。
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