中国食品药品监管2024，Issue(8) ：78-89.DOI:10.3969/j.issn.1673-5390.2024.08.009

用于颠覆式创新的医药产品监管沙盒浅析

A Brief Review on the Sandbox for the Development of the Medicinal Products with Disruptive Innovation

吴婧 吴天贺 姚立新
中国食品药品监管2024，Issue(8) ：78-89.DOI:10.3969/j.issn.1673-5390.2024.08.009
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  • 万方数据

用于颠覆式创新的医药产品监管沙盒浅析

A Brief Review on the Sandbox for the Development of the Medicinal Products with Disruptive Innovation

吴婧 1吴天贺 2姚立新3
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作者信息

  • 1. 武警江西总队医院
  • 2. 埃默里大学
  • 3. 国家药品监督管理局南方医药经济研究所
  • 折叠

摘要

本文回顾了监管沙盒的由来、发展及其特点;结合美国食品药品监督管理局(FDA)紧急使用授权,探讨紧急使用授权与针对金融科技的监管沙盒的相似性;同时简要介绍欧盟《通用药品立法》(提案)及英国药品和健康产品管理局(MHRA)推出的针对人工智能医疗设备的监管沙盒.医药产品监管沙盒不仅能为行业创新提供重要机会,还能为监管机构在创新技术、产品、服务或方法的早期开发阶段获得相关知识提供便利,使得监管机构跟上相关技术发展的步伐,进而有利于确定监管相关创新的最佳方法,并为相关法规的修订提供参考,也可能为上市批准带来更具适应性、灵活性的方法.

Abstract

This paper reviews the origins,development,and characteristics of regulatory sandboxes.It explores the similarities between the FDA's emergency use authorizations for medicinal products and the regulatory sandboxes used in the fintech sector.It also introduces the European Commission's General Pharmaceutical Legislation proposal and the AI Airlock,the regulatory sandbox for AIaMD,established by the UK's Medicines and Healthcare products Regulatory Agency(MHRA)for AI-driven medical devices.Regulatory sandboxes for medicinal products provide important opportunities for disruptive innovations in the industry,and offer regulators insights during the early development stages of new technologies,products,services,or methodologies.This approach helps regulators stay abreast of technological advancements,informs legislative options for regulatory reform,and potentially enables a more adaptive and flexible approach to marketing authorization.

关键词

监管沙盒/《通用药品立法》/紧急使用授权/颠覆式创新/监管灵活性/真实世界应用

Key words

regulatory sandbox/General Pharmaceutical Legislation/emergency use authorization/disruptive innovation/regulation flexibility/real-world application

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出版年

2024
中国食品药品监管
中国医药报社

中国食品药品监管

影响因子：0.099
ISSN：1673-5390
参考文献量1
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