Regulatory Express_July 2026

ICH has adopted Annex 2 to the guideline on Good Clinical Practices (GCPs) E6(R3)

ICH 已采纳《药物临床试验质量管理规范（GCP）E6(R3)》指南附录 2

The FDA has released a final guidance titled: Submitting Continuous Glucose Monitoring Data in Clinical Trials. This document provides technical specifications for submitting continuous glucose monitoring (CGM) data in clinical trials to support a marketing application for a drug or biological product.

FDA 发布了一项题为《在临床试验中提交连续血糖监测数据》的最终指导原则。该文件提供了在临床试验中提交连续血糖监测（CGM）数据的技术规范，以支持药物或生物制品上市申请。

This document explains how companies should send data from special glucose monitors used in clinical trials to the FDA. It says that the data should be organized in a clear and standard way so the FDA can review it easily. The goal is to make sure the data is clear, complete, and easy for the FDA to understand.

该文件说明公司应如何向 FDA 提交临床试验中使用的特殊血糖监测仪产生的数据。文件指出，数据应以清晰、标准化的方式组织，以便 FDA 能够轻松审评。目标是确保数据清晰、完整，并便于 FDA 理解。

FDA is standardizing CGM data submissions to enable consistent review. Missing data transparency, traceability, and CDISC compliance are the highestrisk areas. Sponsors must treat CGM data like high-frequency digital endpoint data, not traditional lab data.

FDA 正在对 CGM 数据提交进行标准化，以实现一致的审评。缺失数据透明度、可追溯性和 CDISC 合规性是风险最高的领域。申办方必须将 CGM 数据视为高频数字终点数据，而不是传统实验室数据。

The EMA has published a revised EMA notice to sponsors on validation and qualification of computerised systems used in clinical trials (May 2026).

EMA 发布了修订版《EMA 关于临床试验中使用的计算机化系统验证和确认的申办方通知》（2026 年 5 月）。

The following updates have been made in this new version:

• Updated regulatory alignment: References revised to align with Regulation (EU) No 536/2014 and ICH GCP E6(R3), replacing earlier directives and E6(R2).

• Risk based validation reinforced: Introduces a stronger fit for purpose, risk proportionate approach to validation of computerized systems, in line with E6(R3) Principle 9.

• Sponsor responsibility clarified: Reaffirms that sponsors retain ultimate responsibility for validation, regardless of vendor involvement.

• Contractual arrangements clarified: Contractual expectations explicitly linked to Annex 1 of the EMA Guideline on computerized systems and electronic data, with inspection access requirements clarified using updated legal references.

• Guidance references updated: Replaces GCP Q&As with references to the EMA Guideline on computerized systems and electronic data in clinical trials (2023).

• This document supersedes the previous version to Sponsors on Validation and Qualification of Computerized Systems Used in Clinical Trials, 07-Apr-2020.

新版本做出以下更新：

• 更新监管一致性：修订引用以与《欧盟条例（EU）No 536/2014》和 ICH GCP E6(R3) 保持一致，替代早期指令和 E6(R2)。

• 强化基于风险的验证：引入更强的适合用途、风险相称的计算机化系统验证方法，与 E6(R3) 原则 9 保持一致。

• 明确申办方责任：重申无论是否涉及供应商，申办方均对验证承担最终责任。

• 明确合同安排：合同要求明确关联至 EMA《临床试验中计算机化系统和电子数据指南》附录 1，并使用更新后的法律引用明确检查访问要求。

• 更新指导参考：以《EMA 临床试验中计算机化系统和电子数据指南》（2023）相关引用取代 GCP 问答。

• 本文件取代 2020 年 4 月 7 日发布的上一版《临床试验中使用的计算机化系统验证和确认申办方通知》。

The FDA has issued final guidance on postapproval pregnancy safety studies for drugs and biologics. The guidance updates the agency's 2019 draft recommendations and focuses on how sponsors should collect, monitor, and assess pregnancy safety data once products are in routine clinical use. The document also reflects the growing use of RWD and observational research methods to strengthen evidence generation in populations not routinely included in clinical trials.

FDA 已发布有关药物和生物制品上市后妊娠安全性研究的最终指导原则。该指导原则更新了该机构 2019 年的草案建议，并重点说明在产品进入常规临床使用后，申办方应如何收集、监测和评估妊娠安全性数据。该文件还反映了越来越多使用真实世界数据（RWD）和观察性研究方法，以加强通常未纳入临床试验人群的证据生成。

Since pregnant women are typically excluded from clinical trials, robust postmarketing, real-world evidence (especially pregnancy registries combined with complementary studies) is essential to reliably assess drug safety in pregnancy and inform labeling. The goal is to generate information that can be included in drug labeling to help healthcare providers and patients make informed decisions.

孕妇通常被排除在临床试验之外，因此稳健的上市后真实世界证据（尤其是妊娠登记研究结合补充性研究）对于可靠评估妊娠期间用药安全性并为标签/说明书提供信息至关重要。目标是生成可纳入药品标签的信息，帮助医务人员/医疗卫生人员和患者做出知情决策。

FDA announced the launch of its first real-time clinical trials (RTCT) pilot, a voluntary program that enables FDA reviewers to access pre-specified safety signals and clinical endpoints in near real time while a clinical trial is ongoing. The pilot is designed to reduce administrative and data processing delays that occur between and after clinical phases, while maintaining existing safety, evidentiary, and regulatory standards. FDA leadership emphasized that the RTCT pilot does not replace traditional submissions but serves to inform future efforts.  

FDA 宣布启动其首个实时临床试验（RTCT）试点，这是一项自愿性项目，使 FDA 审评人员能够在临床试验进行期间近实时访问预先指定的安全性信号和临床终点。该试点旨在减少临床阶段之间及之后发生的行政和数据处理延迟，同时保持现有的安全性、证据和监管标准。FDA 领导层强调，RTCT 试点并不取代传统提交，而是用于为未来工作提供参考。

The FDA launched two proof-of-concept real-time clinical trials with AstraZeneca and Amgen and is seeking input on a broader pilot program that could allow continuous clinical development through earlier agency access to trial signals. The FDA's real-time clinical trial initiative could reshape sponsor engagement and internal review workflows by shifting to more flexible communication, while retaining traditional regulatory touchpoints where needed. FDA officials said the real-time model relies on electronic health record data analyzed against predefined signal criteria set by sponsors, trial sites and the agency.

FDA 已与阿斯利康和安进启动两项概念验证实时临床试验，并正在就一项更广泛的试点项目征求意见，该项目可通过机构更早访问试验信号来支持连续性临床开发。FDA 的实时临床试验倡议可能通过转向更灵活的沟通方式，同时在需要时保留传统监管接触点，从而重塑申办方互动和内部审评工作流程。FDA 官员表示，实时模式依赖于根据申办方、试验中心和该机构预先设定的信号标准进行分析的电子健康记录数据。

The US FDA has released a final guidance titled: Bioanalytical Method Validation for Biomarkers. This guidance helps sponsors of investigational new drug applications (INDs) and applicants of new drug applications (NDAs), biologics license applications (BLAs), and NDA and BLA supplements as well as abbreviated new drug applications (ANDAs), as applicable, to validate bioanalytical methods used to evaluate biomarker concentrations. This guidance can also inform the development of bioanalytical methods used for the analysis of biomarker concentrations in nonclinical study samples.

美国 FDA 发布了一项题为《生物标志物生物分析方法验证》的最终指导原则。该指导原则帮助研究性新药申请（IND）申办方，以及新药申请（NDA）、生物制品许可申请（BLA）、NDA 和 BLA 补充申请以及适用时简略新药申请（ANDA）的申请人，验证用于评估生物标志物浓度的生物分析方法。该指导原则还可为用于分析非临床研究样本中生物标志物浓度的生物分析方法开发提供参考。