中美欧药物临床试验监管实践与启示

摘要/Abstract

摘要：

药物临床试验作为药物研发的关键阶段，是评价药物安全性和有效性的核心环节，也是基础研究与临床应用的关键纽带，具有资源密集度高、耗时长的特点。本研究分析全球临床试验监管体系的现状与发展趋势，重点介绍美国、欧盟和中国在临床试验监管方面的法规要求、近期监管实践和新措施，并结合我国临床试验监管面临的新形势，从临床试验资源配置与管理模式、监管协同和临床试验质量风险信号、新技术赋能监管智能化与数字化、加强能力建设4个方面进行探讨，以期为药物临床试验监管提供新的思路和借鉴，助力我国药物临床试验提质增速。

关键词: 药物临床试验, 临床试验质量管理规范, 质量效率优化, 监管体系, 核查, 国际协同

Abstract:

Drug clinical trials are a critical stage in drug research and development， and the cornerstone for evaluating the safety and efficacy of drugs， also serve as a critical bridge between basic research and clinical application representing a resource-intensive and time-consuming phase. This article analyzes the current status and development trends of global clinical trial regulatory systems， with a focus on introducing the regulatory requirements， recent regulatory practices， and new measures in clinical trial oversight in the United States， European Union， and China. It further explores these findings in the context of emerging trends faced by China's clinical trial regulatory framework， focusing on four key aspects： the allocation of clinical trial resources and management framework， regulatory coordination and risk signals to clinical trial quality， the empowerment of new technologies to advance intelligent and digital regulation， and the enhancement of capacity building， aiming to offer insights and references for enhancing the quality and efficiency of drug clinical trial regulation in China.

Key words: Drug clinical Trial； , Good clinical practice； , Quality-efficiency optimization； , Regulatory system； , Inspection； , International coordination

中图分类号:

孙搏, 梅蕾蕾, 徐瑛, 李刚, 李香玉, 杨美成.

中美欧药物临床试验监管实践与启示 [J]. 中国医药导刊, 2025, 27(6): 548-555.

SUN Bo, MEI Leilei, XU Ying, LI Gang, LI Xiangyu, YANG Meicheng.

Regulatory Practices and Enlightment of Drug Clinical Trials in China， the United State and the European Union [J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2025, 27(6): 548-555.

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