中美欧药物临床试验监管实践与启示
收稿日期: 2025-03-17
录用日期: 2025-08-05
网络出版日期: 2025-08-11
Regulatory Practices and Enlightment of Drug Clinical Trials in China， the United State and the European Union
Received date: 2025-03-17
Accepted date: 2025-08-05
Online published: 2025-08-11
孙搏
,
杨虹志
.
中美欧药物临床试验监管实践与启示
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.
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