2026年版《药物临床试验质量管理规范》关键变化及落实思考

Key changes and implementation considerations for 2026 version of Good Clinical Practice

摘要

目的: 分析2026年版《药物临床试验质量管理规范》(Good Clinical Practice,GCP)的关键变化,思考落实的具体措施。方法: 通过解读新版GCP修订条款及其与2020年版GCP的比较,结合ICH E6(R3)内容,探讨关键变化引发的落实措施。结果: 删除试验方案、研究者手册和必备文件管理及大部分术语,具体参照E6(R3)执行,但保留原则性要求和中国特有规定;总则纳入E6(R3)三大核心理念,明确主要研究者和申办者的最终责任,新增数据治理独立章,理顺安全性报告流程。结论: 为落实新版GCP以助推我国药物临床试验发展,申办者应当对接国际视野、加强责任意识,落实质量管理和数据治理,主要研究者和临床试验机构应增强最终责任意识、明确授权边界,服务供应商依合同合规落实。

Abstract

Objective: To analyze the key changes in the 2026 edition of the good clinical practice (GCP) and to explore specific implementation measures. Methods: By interpreting the revised provisions of the new GCP edition and comparing them with the 2020 edition, together with reference to ICH E6 (R3), this study examines the implementation measures necessitated by these key changes. Results: The provisions regarding the management of trial protocols, investigator's brochures, and essential documents, as well as most terminology, have been removed; implementation now follows ICH E6 (R3) guidelines, while retaining fundamental requirements and China-specific regulations. The General Provisions incorporate the three core principles of the ICH E6(R3), clarify the ultimate responsibilities of the principal investigator and the sponsor, introduce a separate chapter on data governance, and streamline the safety reporting process. Conclusion: To implement the new version of GCP and to promote the development of clinical drug trials in China, sponsors should align with international standards to strengthen their sense of responsibility and implement quality management and data governance; principal investigators and clinical trial institutions should enhance their awareness of ultimate responsibility and clarify the boundaries of authorization; and service providers should perform their duties in compliance with contractual obligations.

关键词

药物临床试验质量管理规范 / ICH E6(R3) / 关键变化 / 落实措施

Key words

Good Clinical Practice / ICH E6 (R3) / key changes / implementation measures

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基金资助

陆军军医大学人文社会科学基金重点资助项目(2022XRW02)