《生命科学》 2026, 38(2): 381-396
生物合成产品国内外监管实践与监管路径探讨
摘 要：
合成生物学正以“设计生命”与“创造价值”双重驱动力重塑生物制造格局，推动产品形态从单一化合物向纯化小分子、复合提取物、灭活菌体及工程化活菌系统等多元化谱系演进。这种“人工设计性”与“生物系统依赖性”特质，对传统监管体系提出了新的适应性要求。本文通过系统解析生物合成化妆品、生物合成食品、农业生物制品及生物合成药品四类代表性产品的监管演进逻辑，揭示监管路径随风险递进而呈现的差异化特征：生物合成化妆品侧重于在现有框架内进行风险分级备案管理；生物合成食品需在既有食品安全标准基础上进行精细化调整，并为细胞培养肉等颠覆性产品构建新型审批通道；农业生物制品监管的关键在于实现从过程监管向基于产品特性与环境风险评估的综合模式转变；而生物合成药品则要求建立以风险防控为核心、覆盖研发至上市后监测的全链条动态监管体系。据此，本文在衔接、调整、突破、创新为内核的动态监管原则的基础上，提出“先简后繁、先低风险后高风险、先试点后推广、先立标准后建体系”的监管路径，旨在探索一条既能筑牢生物安全底线又能充分释放创新活力的科学监管新范式，为渐进式监管体系的构建提供兼具理论深度与实践价值的参考。
通讯作者：李 荣 , Email:rong_li@sinh.ac.cn
Abstract:
Synthetic biology, as a disruptive technology driving the next wave of scientific revolution and industrial transformation, is profoundly reshaping the global biomanufacturing landscape through its dual driving forces of ″designing life″ and ″creating value″. This paradigm shift has propelled product evolution from single compounds to a diversified spectrum encompassing purified small molecules, complex extracts, inactivated microbial cells, and engineered live microbial systems. The inherent ″human-designed attributes″ and ″biological system dependency″ of these products present novel adaptive challenges for traditional regulatory frameworks, which were primarily developed for physical and chemical domains characterized by relative determinism and transparency. Traditional regulatory logic, emphasizing explainability and predictability, struggles to accommodate the unique dual nature of these bio-engineered products. This paper systematically analyzes the regulatory evolution across four representative synthetic biology product categories—biosynthetic cosmetics, biosynthetic foods, agricultural bioproducts, and biosynthetic pharmaceuticals—through an examination of regulatory practices in the United States, European Union, Singapore, and China. The analysis reveals a distinct risk-driven regulatory pattern where the regulatory intensity and paradigm shift intensity increase progressively with risk levels. For biosynthetic cosmetics, characterized by low systemic risk and clear product boundaries, the regulatory core lies in seamless integration with existing frameworks through risk-based classification and registration systems, avoiding costly institutional restructuring. Biosynthetic foods, directly impacting human ingestion safety, require refined adjustments to established food safety standards while establishing novel approval pathways for disruptive innovations like cell-cultured meat. Agricultural bioproducts face dual challenges of ecological safety and biodiversity conservation, necessitating a transition from process-oriented regulation to integrated models emphasizing product-specific traits and environmental risk assessments. Biosynthetic pharmaceuticals, particularly cell and gene therapies, demand comprehensive lifecycle
regulatory innovation, including risk-tiered access mechanisms, AI-enhanced evaluation, and novel standard frameworks. The differentiated regulatory pathways reflect a fundamental principle: the regulatory approach must align with the product′s risk profile and technical characteristics. Based on this analysis, we propose a phased regulatory strategy—″from simplicity to complexity, from low risk to high risk scenarios, from pilot programs to large-scale promotion, and from standard setting to system construction″—as a dynamic regulatory framework built upon the principles of alignment, adjustment, breakthrough, and innovation. This approach aims to forge a scientific regulatory paradigm that simultaneously safeguards biosecurity while unleashing innovation potential, offering both theoretical depth and practical guidance for constructing progressive regulatory frameworks. By adopting this incremental approach, regulatory bodies can effectively balance the imperative of public safety with the need to foster innovation in this rapidly evolving field, ultimately contributing to the global governance of synthetic biology products in a manner that is both scientifically rigorous and practically implementable.
Communication Author：LI Rong , Email:rong_li@sinh.ac.cn
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