干细胞治疗监管模式的国际比较

A comparative analysis of stem cell therapy regulatory models worldwide

摘要

随着干细胞治疗的迅猛发展,其在临床医学中的应用不断拓展,但也给监管体系带来了新的挑战。本文系统梳理了全球多个国家的干细胞治疗监管模式,并在对相关政策法规、技术指南及学术文献进行比较分析的基础上,总结不同国家在风险分级、准入路径与全过程质量管理方面的主要做法与共同趋势,指出各国普遍采用风险分级管理与加速准入机制以平衡疗效与安全性。在对比分析基础上,本文详述了我国干细胞监管体系的演进路径,阐明了“双轨制”(药品化管理与临床研究备案并行)的制度特色。针对当前存在的分类不明、监管碎片化、国际接轨不足等问题,本文提出完善科学分类、健全质量体系、构建临床转化机制、强化伦理与信息公开、深化国际合作五大对策建议,以期推动建立科学、规范、高效的中国特色干细胞治疗监管体系,并为国际监管模式提供借鉴。

Abstract

With the rapid advancement of stem cell therapy, its application in clinical medicine has expanded significantly, posing new challenges to existing regulatory frameworks. This article systematically reviews the regulatory models for stem cell therapy across multiple countries, and based on a comparative analysis of regulatory policies, technical guidelines, and peer-reviewed literature, summarizes the major approaches and common trends regarding risk stratification, access pathways, and lifecycle quality management. The analysis highlights the widespread adoption of risk-based classification and accelerated access mechanisms to balance efficacy and safety. Through comparative analysis, the article details the evolution of China's regulatory system for stem cell therapy, emphasizing the characteristics of the “dual-track” model-parallel management through drug-based regulation and clinical research filing. In response to current issues such as unclear classification, fragmented oversight, and insufficient international alignment, the article proposes five key strategies: establishing scientific classification standards, improving quality control systems, facilitating clinical translation, strengthening ethical oversight and information transparency, and deepening international cooperation. These recommendations aim to support the development of a scientific, standardized, and efficient regulatory framework with Chinese characteristics, while also offering insights for global regulatory practices.

关键词

干细胞治疗 / 监管体系 / 风险分级 / 双轨制 / 国际比较

Key words

stem cell therapy / regulatory system / risk-based classification / dual-track model / international comparison

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