《生命科学》 2025, 37(8): 1054-1063

医学合成生物学的伦理监管进展

仲　玮 , 黄小茹^*

中国科学院大学马克思主义学院，北京 100049

摘　要：

医学合成生物学作为合成生物学在医学领域的创新应用，在疾病检测、精准治疗和生物医药制品研发等方面具有重大潜力，也对国家安全、国际竞争和公众利益具有重要意义，同时技术的颠覆性对生命科学和医学领域伦理监管的前瞻性和有效性提出了更高的要求。现阶段不同国家医学合成生物学的伦理政策焦点与监管模式主要体现在技术研发、产品应用和风险评估三个方面，其治理现状与发展态势也给我国在该领域的监管理念、监管模式和实践路径等提供了启示。

通讯作者：黄小茹 , Email:huangxiaoru@ucas.ac.cn

Ethical regulation and governance of medical synthetic biology

ZHONG Wei , HUANG Xiao-Ru^*

School of Marxism, University of Chinese Academy of Sciences, Beijing100049, China

Abstract:

Medical synthetic biology, as an innovative application of synthetic biology in the field of medicine, has significant potential for disease detection, precision therapy and biomedical product development, as well as national security, international competition and public interest, while the subversive nature of the technology puts forward higher requirements for the foresight and effectiveness of the ethical regulation of countries in the fields of life sciences and medicine. At the present stage, the ethical policy focuses and regulatory models of medical synthetic biology in different countries are mainly reflected in three aspects: technology research and development, product application and risk assessment, and their governance status quo and emerging situation also provide inspiration for China's regulatory concept, regulatory model and practice path in this field.

Communication Author：HUANG Xiao-Ru , Email:huangxiaoru@ucas.ac.cn