An exploration of domestic and international regulatory practices and pathways for synthetic biology products

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.