Closing the gap? China's new regulation on biomedical technologies.

IF 5.6 2区医学 Q1 CELL & TISSUE ENGINEERING

Stem Cell Reports Pub Date : 2026-07-14 Epub Date: 2026-06-25 DOI:10.1016/j.stemcr.2026.102978

Ubaka Ogbogu

引用次数: 0

Abstract

This paper discusses China's State Council Order No. 818, effective May 1, 2026, which establishes a statutory framework for biomedical technologies at the cellular and molecular levels. The framework is uniquely intervention-based rather than product-based, and it addresses regulatory gaps for cell and gene therapies as well as germline interventions.

查看原文本刊更多论文

缩小差距？中国对生物医学技术的新规定。

本文讨论了2026年5月1日生效的中国国务院第818号命令，该命令为细胞和分子水平的生物医学技术建立了法定框架。该框架是基于干预而不是基于产品的独特框架，它解决了细胞和基因治疗以及种系干预的监管空白。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Stem Cell Reports CELL & TISSUE ENGINEERING-CELL BIOLOGY

CiteScore

10.50

自引率

1.70%

发文量

200

审稿时长

28 weeks

期刊介绍： Stem Cell Reports publishes high-quality, peer-reviewed research presenting conceptual or practical advances across the breadth of stem cell research and its applications to medicine. Our particular focus on shorter, single-point articles, timely publication, strong editorial decision-making and scientific input by leaders in the field and a "scoop protection" mechanism are reasons to submit your best papers.