Regulatory Express_Apr. 2025

PMDA发布了2022年4月至2023年3月和2023年4月至2024年3月的GCP检查结果总结；

关键信息：

• 总计包括PMDA进行的GCP检查数量以及研究中心和申办方的发现总结/示例等。

• 对于研究中心的GCP现场检查，

• 2023年4月至2024年3月，11/204个研究中心收到了PMDA给出的不符合项。

• 排名前2位的不符合项类别是：外包合同和知情同意，与前一年相同。

• 此外，还发现了与PI/Sub-I要求、CRF、PD、记录管理有关的不符合项。

• 对于申办方的现场检查：

• GCP现场检查：2023年4月至2024年3月期间共进行了100次检查，其中98次符合规定，2次有条件符合规定，无不符合规定的情况。

• 上年度检查108项，全部符合规定。2年期间，PMDA共发现了12个不符合项，如外包合同、IP、方案、监查、ADR报告和稽查。

• 基于文件的符合性检查：从2023年4月到2024年3月，进行了126次检查，其中120次符合规定，6次有条件符合规定，，没有不符合规定的情况。前一年也进行了126次检查，其中4次有条件符合规定，，没有不符合规定的情况。

The PMDA has released a summary of the GCP inspection results from Apr in 2022 to Mar in 2023 and from Apr in 2023 to Mar in 2024; 

Key Takeaways:

• The materials include the number of GCP inspections conducted by PMDA and the findings summary/examples for Site and Sponsor etc.

• For GCP On-site inspection for Investigator sites,

• 11 out of 204 sites were notified the findings by PMDA from Apr in 2023 to Mar in 2024.

• Top 2 finding category were: Outsourcing contracts and IC, and it was the same the previous year.

• In addition, the findings of PI/Sub-I requirements, CRF, PD, record management were identified.

• For Sponsor inspection,

• GCP On-site inspection: 100 inspections were conducted, of which 98 were compliant, 2 were conditionally compliant and no non-compliant from Apr in 2023 to Mar in 2024.

• on the previous year, 108 inspections were conducted, and all were compliant. Over the 2 years, total 12 findings were identified by PMDA such as Outsourcing contracts, IP, Protocol, Monitoring, ADR reporting and Audit.

• Document based compliance inspection: 126 inspections were conducted, of which 120 were compliant, 6 were conditionally compliant and no non-compliant from Apr in 2023 to Mar in 2024. The previous year had also 126 inspections, of which 4 were conditionally compliant and no non-compliant.

HMA临床试验协调组发布了试验申办方变更指南。

• 本申办方变更指南描述了申办方正确的行动顺序，以及评估申办方法人实体（申办方Org-ID）变更的快速程序。根据EudraLex第10卷CTR问答附件IV，申办方法律实体的变更被视为实质性修改。

关键信息：

• “CTCG申办方变更指南”为申办方提供了关于临床试验申办方变更过程的综合指南。

• 概述了必要的文件、通知监管机构的步骤和提交时间表。

• 本指南强调了原申办方和新申办方的角色和职责，以确保试验管理的连续性和数据的完整性。

The HMA Clinical Trials Coordintation Group has released a Guide for Change of Trial Sponsor.

• This sponsor guide describes the correct sequence of actions for sponsors as well as the expedited procedure for the assessment of a change of sponsor legal entity (sponsor Org-ID). A change of sponsor legal entity is considered a substantial modification according to Annex IV of the CTR Questions and Answers at EudraLex Volume 10.

Key Takeaways:

• The "CTCG Sponsor Guide for Sponsor Change" provides comprehensive guidance for sponsors on the process of changing the sponsor of a clinical trial.

• It outlines the necessary documentation, steps to notify regulatory authorities, and timelines for submission.

• The guide emphasizes the roles and responsibilities of both the original and new sponsors to ensure continuity of trial management and data integrity.

TGA已发布其药物警戒检查项目指标报告：2022年1月-12月。

TGA在进行检查时采取基于风险的方法。考虑的风险因素包括申办方的：

• 产品

• 药物警戒系统

• 合规历史

• 相似的海外监管者检查的最新历史

• 对两年一次的PVIP风险评估调查的答复

关键信息：

• 2022年的检查数量与上一年保持一致。

• 以下主题领域的缺陷占比最高，与分级无关。

• 收集和汇总药物不良反应（占所有缺陷的14.5%）

• 不良反应管理（占所有缺陷的12.9%）

• 报告不良反应（占所有缺陷的11.2%）

• 2022年的4个严重缺陷

• 药物不良反应的收集和汇总(1)

• 报告不良反应(1)

• 持续安全性评估(1)

• 安全性参考信息管理(1)

The TGA has released their Pharmacovigilance Inspection Program metrics report: Jan - Dec 2022.  

The TGA takes a risk based approach in conducting inspections.  Risk factors that are considered include the sponsor's:

• Products

• Pharmacovigilance system

• Compliance history

• Recent history of inspections by Comparable Overseas Regulators (CORs)

• Responses to the biennial PVIP Risk Assessment Survey

Key Takeaways:

• The number of inspections in 2022 remain the same as the previous year.

• The following topic areas have represented the highest proportion of deficiencies regardless of grading this year.

• Collection and collation of adverse drug reactions (14.5% of all deficiencies)

• Management of Adverse Reactions (12.9% of all deficiencies)

• Reporting Adverse Reactions (11.2 % of all deficiencies)

• 4 Critical Findings in 2022

• Collection and Collation of Adverse Drug Reactions (1)

• Reporting Adverse Reactions (1)

• Ongoing Safety Evaluation (1)

• Management of Reference Safety Information (1)

EMA发布了一份指南，标题为：关于临床试验信息系统(CTIS)中个人数据处理的数据保护通知。

关键信息：

本数据保护通知解释了CTIS中个人数据处理的最基本细节，包括：

• 临床试验应用领域和试验生命周期中的监督。该信息通过EU门户网站的安全域提交，并存储在EU数据库中；

• 年度安全性报告(ASR)的提交和评价领域。

The EMA has released a guidance titled: Data protection notice regarding personal data processing in the Clinical Trials Information System (CTIS).

Key Takeaways:

This Data protection notice explains the most essential details of the processing of personal data in CTIS, which includes:

• the area of clinical trials applications and supervision during the trial lifecycle. This information is submitted through the secure domain of the EU Portal and stored in the EU Database;

• the area of submission and evaluation of annual safety reports (ASRs).

截至2月2日，欧盟AI法案的第一条规则已开始适用，包括AI系统定义和禁止的AI实践。欧盟委员会发布了涉及这两个领域的指导性文件。

As of 2nd February, the first rules under the EU AI Act have started to apply, including those relating to the AI system definition and prohibited AI practices. The European Commission has released guidance documents addressing these two areas.

EMA发布了关于临床试验中试验性先进治疗药品质量、非临床和临床要求指导原则的最终指南。

关键信息：

• 本指导原则旨在帮助研发者设计和构建试验性ATMP的临床试验申请，确保在考虑这些治疗的独特特征时符合安全性标准和法律要求。

该指导原则是多学科的，涉及试验性ATMP的开发、生产和质量控制以及非临床和一定程度上的临床方面。

The EMA has released a final guidance on Guideline on quality, non-clinical and clinical requirements for investigational advanced therapy medicinal products in clinical trials.  

Key Takeaways:

• The guideline aims to assist developers in designing and structuring clinical trial applications for investigational ATMPs, ensuring compliance with safety standards and legal requirements while considering the unique characteristics of these therapies.

The guideline is multidisciplinary and addresses development, manufacturing and quality control as well as non-clinical and to some extent, clinical aspects of investigational ATMPs.

MHRA发布了一份指南，标题为：药物临床试验：管理您的授权，报告安全性问题。

关键信息：

• 本文件提供了关于如何变更方案、更新授权、报告安全性问题、提交安全性更新和完成试验结束研究报告的指南。

• 该版本更新了开发安全性更新报告(DSUR)章节，包括新的用户参考指南。

The MHRA has released a guidance titled: Clinical trials for medicines: manage your authorisation, report safety issues.  

Key Takeaways:

• This document provides guidance on how to change protocol, update authorization, report safety issues, submit safety updates and complete end-of-trial study report.

• This version makes updates to the section on development safety update reports (DSURs) including a new user reference guide.

MHRA发布了一系列医疗器械相关指南：上市后监督，如下所示。

指南：上市后监管要求

• 医疗器械（上市后监管要求）（修正案）（英国）法规2024：实施指南

        关于生产商警戒系统的补充指南

• 有效的现场安全通知-医疗器械生产商指南（网站更新）

• 应在警戒系统下报告的事件示例  

        定期安全性更新报告

• 医疗器械（上市后监管要求）（修正案）（英国）法规2024：定期安全性更新报告(PSUR)的标准化格式

• 医疗器械（上市后监管要求）（修正案）（英国）法规2024：批准机构定期安全性更新报告(PSUR)指南（法规44ZM）

        器械特定警戒指南

• 不良事件：体外诊断(IVD)血糖仪

• 报告不良事件：人工晶状体

• 报告不良事件：关节置换植入物

• 报告不良事件：神经刺激器

• 报告不良事件：乳房植入体

• 报告不良事件：胰岛素泵和血糖仪系统

• 报告不良事件：心脏消融器械

• 报告不良事件：作为医疗器械的软件

        关键信息：

• 这些指南为医疗器械生产商提供了上市后监督、向MHRA报告不良事件和现场安全纠正措施的信息。

The MHRA has released a collection of Guidances Medical devices: post-market surveillance listed below. 

Guidance: Post-market surveillance requirements  

• The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on implementation

          Supplementary guidance on a manufacturer's vigilance system 

• Effective field safety notices – guidance for manufacturers of medical devices (website update) 

• Examples of incidents which should be reported under the vigilance system  
  

          Periodic safety update reports 

• The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: standardised format for periodic safety update report (PSUR)

• The Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024: guidance on periodic safety update reports (PSUR) (regulation 44ZM) for approved bodies 
  

          Device-specific vigilance guidance

• Adverse incidents: in vitro diagnostic (IVD) blood glucose meters

• Reporting adverse incidents: intraocular lenses

• Reporting adverse incidents: joint replacement implants

• Reporting adverse incidents: neurostimulators

• Breast implants: reporting adverse incidents

• Reporting adverse incidents: insulin pumps and meter systems

• Reporting adverse incidents: devices for cardiac ablation

• Reporting adverse incidents: software as a medical device

          Key Takeaways:

• These guidances provide information for manufacturers of medical devices on post-market surveillance, reporting adverse incidents and field safety corrective actions to the MHRA.

MHRA发布了一份指南，题为：数字精神卫生技术：资格认定和分类。数字精神卫生技术(DMHTs)是旨在支持精神健康和福祉的软件产品和相关硬件。

关键信息：

• 本指南文件帮助生产商识别其DMHT的具体特征，并确定其是否被视为SaMD。如果是SaMD，该指南将有助于确定适当的器械分类。

The MHRA has released a guidance titled: Digital mental health technology: qualification and classification.  Digital mental health technologies (DMHTs) are software products and related hardware that aim to support mental health and wellbeing. 

Key Takeaways:

• This guidance document helps manufacturers identify the specific characteristics of their DMHT and determine whether it is considered as SaMD. If it is SaMD, the guidance will help determine the appropriate device classification.

美国FDA发布了一份标题为“机构审查委员会常见问题”的信息表。

本文件（以网站的形式）是对FDA提出的关于研究中保护人类受试者的问题的答案的汇编。为便于参考，本节中分配给问题的编号是连续的。这些问题和答案根据以下主题进行组织。

• IRB组织

• IRB成员

• IRB程序

• IRB记录

• 知情同意过程

• 知情同意文件内容

• 临床研究

• 一般问题

The US FDA has released an information sheet titled: Institutional Review Boards Frequently Asked Questions.

The document (in the form of a website) is a compilation of answers to questions asked of FDA regarding the protection of human subjects of research. For ease of reference, the numbers assigned to the questions are consecutive throughout this section. These questions and answers are organized under the following topics.

• IRB Organization

• IRB Membership

• IRB Procedures

• IRB Records

• Informed Consent Process

• Informed Consent Document Content

• Clinical Investigations

• General Questions

本专家评审报告旨在回答以下问题：

• 社交媒体数据如何支持监管决策？监管用例和社交媒体数据的附加价值是什么？

• 考虑到与RWD和社交媒体数据相关的最新技术、方法学和监管发展，目前社交媒体数据用于监管决策的挑战和机遇是什么？

• 为了在欧盟监管决策中使用社交媒体数据并确立其价值，未来行动的可能考虑要点是什么？

关键信息：

• 本报告审查了通过Embase数据库文献检索识别出的73篇相关科学文献和综述。

• 这些论文的研究结果被用来为社交媒体数据制定一套监管用例，并确定与其使用相关的挑战和机遇。

• 最终，提出7点供未来行动考虑，以确立价值，并使社交媒体数据能够用于医学监管。

This expert review report aims to answer the following questions:

• How can social media data support regulatory decision-making? What are the regulatory use cases and the additional value of social media data?

• Considering the latest technological, methodological, and regulatory developments related to RWD and social media data, what are the current challenges and opportunities for the use of social media data in regulatory decision-making?

• What are the possible points for consideration for future actions to enable the use and establish the value of social media data into the EU regulatory decision-making?

Key Takeaways:

• The current report reviewed 73 relevant scientific articles and reviews identified through a literature search on the Embase database.

• Findings from these papers were used to formulate a set of regulatory use-cases for social media data, as well as to identify relevant challenges and opportunities related to their use.

Ultimately, 7 points for consideration for future actions are proposed to establish value and enable the use of social media data in medicine regulation.

HMA/EMA关于在上市许可申请（MAA）文件结构中识别个人数据和商业机密信息的指南文件。

关键信息：

• 在这个新版本中，对以下章节进行了修改：

• 与没有法定职责的工作人员有关的个人数据

• 用于商业机密信息（CCI）编辑的原则

• 附件：上市许可申请资料结构中可能被视为受保护的个人数据(PPD)和/或商业机密信息(CCI)的信息。

• 定义

The HMA/EMA guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorization application (MAA) dossier.  

Key Takeaways:

• In this new version, the following sections have been modified:

• Personal data related to staff with no legally defined responsibilities

• Principles to be applied for the redaction of commercially confidential information (CCI)

• Annex: Information that may be considered protected personal data (PPD) and/or commercially confidential information (CCI) in the structure of the marketing authorization application dossier.

• Definitions

MHRA发布了一份文件，标题为：适用于英国上市许可持有人和许可持有人的欧盟药物警戒质量管理规范指南的例外情况和修改。（版本3.0）

• 本指导原则说明了许可机构对欧盟委员会GVP指导原则规定的判定，即不再适用于许可机构和英国MAH或待修订后解读。

关键信息：

• 更新了第3版，以反映根据Windsor框架协议实施新药品安排的英国立法的变更，并更新了欧盟GVP模块XVI和附录II，以纳入新的联系方式。

The MHRA has issued a document titled: Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK marketing authorisation holders and the licensing authority. (Version 3.0)

• This guidance note sets out the licensing authority's determination as to the provisions of the Commission's GVP guidance that no longer apply to the licensing authority and UK MAHs or are to be read subject to modification. 

Key Takeaways:

• Version 3 was updated to reflect the changes to UK legislation implementing new arrangements for medicines following agreement of the Windsor Framework, and the European Union updates to GVP module XVI and Addendum II Updated to include new contact details.

MHRA发布了几份药物警戒相关文件。

• 药物警戒程序指南

• 添加到Windsor Framework上的指导和网络研讨会的链接

• MAH和QPPV位置指南

• 更新了Windsor框架的实现，以说明第1类和第2类产品的要求。

• 药物警戒负责人（ QPPV ）指南，包括药物警戒系统主文件（ PSMF ）

• 更新了Windsor框架的实现，以说明第1类和第2类产品的要求。

• PSMF可及性-增加句子，说明PSMF发送给许可机构时必须是最新的。

关键信息：

• 经Windsor Framework协议，MHRA发布了描述2025年1月1日起适用于英国药物警戒要求变更的指南。

• MHRA已修订了其他指南页面，以反映Windsor框架的实施。

The MHRA has released several documents related to Pharmacovigilance.

• Guidance on Pharmacovigilance Procedures

• Links added to guidance and webinar on Windsor Framework

• Guidance on MAH and QPPV location

• Updates made to indicate requirements for Category 1 and Category 2 products following the implementation of the Windsor Framework.

• Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

• Updates made to indicate requirements for Category 1 and Category 2 products following the implementation of the Windsor Framework.

• PSMF accessibility – Sentence added to state that PSMF must be up to date at the point it is sent to the licensing authority.

Key Takeaways:

• Following the agreement of the Windsor Framework, the MHRA has published guidance describing the changes to Pharmacovigilance requirements applicable in the UK from 01-Jan-2025.

• The MHRA has revised additional guidance pages to reflect the implementation of the Windsor Framework.

EMA已经发布了特定不良反应随访问卷指南（特定AR FUQ）的最终版本，该指南于2025年2月1日生效。  本文旨在为EU/EEA监管药品网络提供关于在常规药物警戒活动中何时以及如何使用特定不良反应随访问卷（特定AR FUQ）的指导（GVP模块V，V.B.6.1.1.）。

关键信息：

• 本新指南描述了何时以及如何将这些随访问卷作为风险管理的一部分，以补充GVP模块V（风险管理系统）和VI（ICSR管理），提高药物警戒信息的完整性。

• 本文件还为MAH制定特定AR FUQ以及终止和删除这些FUQ提供了指导。

• 本文件确定了三个主要方向：

• 提供何时以及如何使用特定AR FUQ的一般指导

• MAH制定特定AR FUQ的指南，以及

• 考虑终止和删除特定AR FUQ。

The EMA has published the final version of the Guideline on specific Adverse Reaction Follow-Up Questionnaires (Specific AR FUQs), which came into effect on 01-Feb-2025.  This paper aims at providing a guidance to the EU/EEA regulatory medicines network on when and how to use specific adverse reaction follow-up questionnaires (Specific AR FUQs) in routine pharmacovigilance activities (GVP module V, V.B.6.1.1.).

Key Takeaways:

• This new guideline describes when and how to use these Follow-Up Questionnaires as part of risk management to improve the completeness of Pharmacovigilance information, in complement to GVP modules V (Risk Management Systems) and VI (ICSR Management).

• The document also provides guidance for MAHs on developing Specific AR FUQs, and for their discontinuation and removal.

• The document identifies three main directions:

• providing general guidance on when and how to use Specific AR FUQs,

• guidance for MAHs on developing Specific AR FUQs, and

• considering discontinuation and removal of Specific AR FUQs.

更新：今天EMA采纳了ICH E6（ R3 ）药物临床试验质量管理规范指南。 本文件所列生效日期为2025年7月23日。

ICH E6（R3）“药物临床试验质量管理规范”指导原则于2025年1月6日进入ICH进程第四阶段。该指导原则建立在ICH E8（R1）临床研究的一般考虑中所概述的关键概念的基础上。这包括培养质量文化，主动将质量设计到临床试验和药物研发计划中，识别对试验质量至关重要的因素，酌情吸引相关方，并使用相应的基于风险的方法。

关键信息：

• 修订通过实施基于风险的方法、提高透明度和促进有效监督，为临床研究的原则和实践带来了重大变化，修订旨在提高试验参与者保护和数据完整性。

• 下一步是各个卫生监管部门采纳该指南。当我们审查本最终指南时，可能会进行额外的分析。

Update: Today the EMA adopted the ICH E6(R3) Good Clinical Practice Guideline.  The effective date listed on the document is 23 July 2025.

The ICH E6(R3) "Good Clinical Practice" Guideline reached Step 4 of the ICH process on 6 January 2025.   The Guideline builds on key concepts outlined in ICH E8(R1) General Considerations for Clinical Studies. This includes fostering a quality culture and proactively designing quality into clinical trials and drug development planning, identifying factors critical to trial quality, engaging interested parties, as appropriate, and using a proportionate risk-based approach.

Key Takeaways:

• The revision brings significant changes to the principles and practices of clinical research by implementing risk based methods, enhancing transparency, and promoting efficient oversight the revision aims to improve trial efficiency participant protection and data integrity.

• The next step is for individual health authorities to adopt this guideline.  Additional analysis may become available as we review this final guidance.

美国FDA发布了标题为“生物标记物的生物分析方法验证”的最终指南。

什么是生物标志物？

• 生物标记物是身体的可测量特征，表示正常或异常过程、状况或疾病。

生物标记物如何用于药物开发？

• 生物标记物用于药物开发，以测量药物对患者身体的影响。

• 它们可以帮助确定一种药物是否安全有效，以及哪些患者最有可能从中获益。

• 生物标记物也用于帮助指导临床试验设计和监管决策。

• 用于评估新药和治疗性生物制品在特定患者人群中的作用。

验证分析方法可通过解决以下关键问题确保数据的可靠性：

• 该方法是否可测量预期分析物？

• 与这些测量相关的变异性是什么？

• 提供可靠数据的测量范围是多少？

• 样本采集、处理和储存如何影响生物分析方法所得数据的可靠性？

关键信息：

• 本指南的目的是阐述如何按照行业指南M10生物分析方法验证和研究样品分析（2022年11月）的原则阐述生物标记物的生物分析方法验证。

The US FDA has published a final guidance titled: Bioanalytical Method Validation for Biomarkers. 

What is a biomarker?

• A biomarker is a measurable characteristic of the body that indicates a normal or abnormal process, condition, or disease.

How are Biomarkers used in drug development?

• Biomarkers are used in drug development to measure the effects of a drug on a patient's body.

• They can help determine if a drug is safe and effective, and which patients are most likely to benefit from it.

• Biomarkers are also used to help guide clinical trial design and regulatory decision making.

• They are used to assess the effects of new drugs and therapeutic biological products in specific patient populations.

Validating the analytical method ensures that the data are reliable by addressing certain key questions, including:

• Does the method measure the intended analyte?

• What is the variability associated with these measurements?

• What is the range in measurements that provide reliable data?

• How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method?

Key Takeaways:

• The purpose of this guidance is to address how bioanalytical method validation for biomarkers should be addressed consistent with the principles of the guidance for industry M10 Bioanalytical Method Validation and Study Sample Analysis (November 2022). 

根据中心刚刚发布的2024年年度报告，2024年，CDRH批准了120种新型器械的上市许可，比前一年的124种器械少了4种。该中心还看到开发人员越来越有兴趣将他们的新技术首先在美国或与其他主要国家同步上市。根据报告，2024年，65%的新型器械首次在美国上市，高于2022年首次在美国上市的55%。

关键信息：

本报告列出了CDRH在以下方面的成就和活动：

• 国际协调、供应链弹性、器械安全（亦称强制执行）和器械创新。

• 此外，CDRH表示，其于2024年致力于进一步推广使用真实世界数据和真实世界证据（RWE)来代替传统临床试验数据，从而缩短回答重要器械问题的时间。“我们已经授权了超过180台设备，至少部分基于RWE——其中50台将在2024财年发布”。。“对于那些需要安全有效的选择来改善和延长生命的患者来说，这些代表着重要的进步”。

In 2024, CDRH granted marketing authorization to 120 novel devices, which was four less than the previous year’s record-setting 124 devices, according to the Center’s just-released 2024 annual report. The Center also continues to see increasing interest from developers to bring their novel technologies to market first in the U.S or in parallel with other major countries. In 2024, 65% of novel devices were first introduced in the U.S., which is up from 55% that were first marketed in the U.S. in 2022, according to the report.

Key Takeaways:

This report list CDRH's wins and activities regarding:

• International Harmonization, Supply Chain Resiliance, Device Safety (aka enforcement) and Device Innovation.

• Additionally, CDRH says it worked in 2024 to further promote the use of real-world data and real-world evidence (RWE) in lieu of conventional clinical trial data to reduce the time to answer important device questions. “We have authorized more than 180 devices, at least in part on the basis of RWE — with 50 in FY2024,” it says. “These represent important advancements for patients who need safe and effective options to improve and extend their lives.”

EMA检查员工作组已发布2023年的年度检查报告。下面是对过去4年的研究结果的比较。

关键信息：

• 与前几年一样，大多数（69%)）CHMP GCP检查在临床研究中心进行，其次是申办方 （24%）和CRO（1.5%）。

• 检查总数比上年增加46%。

• 2023年，该机构没有像过去几年那样开展任何远程/混合检查.

• 本年度不包括质量体系这一类别。

• 任何级别（主要、次要和关键）结果总数的前3位主要类别为：试验管理、一般、研究中心。

The EMA Inspectors Working Group has released its annual inspection report for the year 2023.  Below is a comparison of findings for the past 4 years.

Key Takeaways:

• As in previous years, the majority (69%) of CHMP GCP inspections were carried out on Clinical Investigator sites, followed by Sponsor Sites (24%) and CROs (1.5%). 

• The total number of inspections increased by 46% from the prior year.

• In 2023, the agency did not note any remote/ hybrid inspections as they have in the past several years

• This year did not include the category of Quality System. 

• The top 3 Main categories with overall number of findings in any grade (major, minor, and critical) were: Trial Management, General, Investigational Site).

EMA发布了一份新文件：附件I：关于在使用临床试验信息系统（CTIS ）时如何保护个人数据和商业机密信息的指南文件。

• 本文件提供了关于临床试验中处理个人数据和商业机密信息的综合指南。它强调了保护此类数据的重要性，并概述了法律和道德义务。

• 关键原则包括数据最小化、匿名化、假名化和透明度。

在这个新版本中，对以下章节进行了修改：

• 定义

• 本文件取代之前版本的EMA/194159/2023：附件1-关于在使用临床试验信息系统（ CTIS）1.2版（2024年6月18日）时如何保护个人数据和商业机密信息的指南文件。

• 网站未提供本文件发表的具体日期。因此，所示的发表日期仅为基于可用信息的估计值。

The EMA has published a new document: Annex I: Guidance document on how to approach the protection of personal data and commercially confidential information while using the Clinical Trials Information System (CTIS).

• The document provides comprehensive guidelines on handling personal data and commercially confidential information in clinical trials. It emphasizes the importance of protecting such data and outlining legal and ethical obligations.

• Key principles include data minimization, anonymization, pseudonymization, and transparency.

In this new version, the following section has been modified:

• Definitions

• This document supersedes the previous version EMA/194159/2023: Annex 1 - Guidance Document on how to Approach the Protection of Personal Data and Commercially Confidential Information While Using the Clinical Trials Information System (CTIS) Version 1.2, 18-Jun-2024.

• The website did not provide a specific date for the publication of this document. Therefore, the publication date indicated is only an estimate based on the available information.