全球科技经济瞭望2026，Vol.41Issue(4)：21-29,9.DOI:10.3772/j.issn.1009-8623.2026.04.003
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 Sandboxes for China
摘要
Abstract
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.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Key words
Regulatory Sandbox/Biomedicine/Regulatory Science/International Comparison/Agile Regulation/Institutional Innovation分类
社会科学引用本文复制引用
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):21-29,9.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). （25692122300）
