| 陈莹,武雨婷.美国、英国生物医药领域监管沙盒实践及对中国的启示[J].全球科技经济瞭望,2026,41(4):21~29 |
| 美国、英国生物医药领域监管沙盒实践及对中国的启示 |
| Insights from US and UK Biomedical Regulatory Sandboxesfor China |
| 投稿时间：2026-02-09 |
| DOI： |
| 中文关键词: 监管沙盒；生物医药；监管科学；国际比较；敏捷监管；制度创新 |
| 英文关键词: Regulatory Sandbox; Biomedicine; Regulatory Science; International Comparison; Agile Regulation; Institutional Innovation |
| 基金项目:上海市 2025 年度高水平机构建设运行计划“软科学研究”项目“重点新兴领域政策供给与沙盒监管研究”（25692122300）。 |
|
| 摘要点击次数: 40 |
| 全文下载次数: 36 |
| 中文摘要: |
| 生物医药颠覆性技术对传统监管体系构成挑战，监管沙盒是一种在受控环境下测试创新、平衡
安全与效率的适应性治理工具，正被美国和英国等国探索应用。梳理与比较两国生物医药领域监管沙
盒的典型实践，分析其运行机制及成效。发现两国基于不同的制度环境，分别形成了“嵌入式制度沙盒”
与“专题性项目沙盒”两种模式。实践中两国也面临共性挑战：沙盒准入标准在精准筛选与创新灵活性
之间难以平衡；高强度监管合作的可持续性存疑；小范围证据推广时代表性有限；国际协调与互认机制
尚不健全。监管沙盒的有效运行有赖于与本土生态的深度融合，其成功依赖于监管角色转型、机制动态
适配及治理能力持续提升，英美经验为中国构建生物医药监管沙盒提供了可操作的参考框架。 |
| 英文摘要: |
| A regulatory sandbox is an adaptive governance tool designed to address the challenges posed
by disruptive biomedical technologies, aiming to balance safety and efficiency by testing innovations within a
controlled environment. This paper systematically reviews and compares the typical practices in the biomedical
biomedical field of the two countries, and analyzes their operational mechanisms and outcomes. This study
finds that, based on different institutional environments, the two countries have developed two distinct models:
the“embedded institutional sandbox” and the“thematic project sandbox.” In practice, both countries also
face common challenges. Balancing precise screening against flexibility in innovation remains difficult. The
sustainability of intensive collaborative efforts is questionable. The risk of evidence being limited when extended
to broader populations is a concern. International coordination and mutual recognition mechanisms are still
inadequate. A regulatory sandbox is a systemic project that integrates deeply with the local ecosystems. Its
success depends on the transformation of the regulatory role from“traditional review” to“proactive guidance and
framework design,” dynamic adaptation of mechanisms, and continuous improvement of governance capacity.
This study provides an actionable reference framework for building biomedical regulatory sandboxes in China. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
| 关闭 |
