目的: 梳理合成生物学技术在天然产物来源药物研制领域的应用和发展路径,促进新技术合理利用、产业高质量发展。方法: 从我国药品注册管理分类出发,梳理相关法规要求,讨论应用合成生物学技术研制天然产物来源药物申报路径。同时基于现有药物研制指南、规范,探讨合成生物学技术应用于此类药物研制相关的技术要求。结果与结论: 基于我国药品注册分类的申报路径分析发现,对于应用合成生物学技术开发的天然产物来源药物,如按中药或天然药物进行注册申报,法规上没有明确的障碍,但现行技术指导原则不适用。若为结构明确、单一的化合物可按化学药研究申报,但需要综合考虑国内外技术要求,或者跨类别参考生物制品相关要求开展研究。还有部分可能发生注册类别的变化,按生物制品管理。现有药物研发的法规和技术要求基本可覆盖此类药物研制的各个阶段,但如何合理适用和借鉴尚未有官方的明确意见,有必要进一步梳理,为产业提供更明确的指导,从而促进新兴技术在保证安全性、有效性的基础上合理应用,推动产业高效率、高质量发展。
Objective: To study the application and development path of synthetic biology technology in the field of natural product-derived drugs, so as to promote the rational application of synthetic biology technology and the high-quality development of the industry in this field. Methods: Based on the national classification of drug registration management, the relevant laws and regulations were analyzed to study the application of synthetic biology technology to develop the natural product-derived drugs. At the same time, the technical requirements of synthetic biology technology applied to the development of such drugs were studied based on the current drug developing guidelines and specifications. Results and Conclusion: By analyzing the national application path of drug registration classification, it could be concluded that, for the natural product-derived drugs which developed with the synthetic biology technology, there are no stated obstacles in the statutes preventing their registration as traditional Chinese medicine or natural drugs, however, the current technical guidelines are not applicable. If it is a single compound and its structural is identified, it could be registered as the chemical drugs, but the domestic and foreign technical requirements should be considered comprehensively, or some relevant requirements for biological products can be referred to if necessary. Sometimes such drugs may be required to be managed as biological products. The existing regulations and technical requirements for drug research could basically cover the different stages of the development of such drugs, however, there is no clear official guidance on how to reasonably apply them. Further official interpretation is necessary to provide more clear guidance for the industry, so as to promote the rational application of emerging technologies on the basis of ensuring safety and effectiveness, and to promote the high-efficiency and high-quality development of the industry.
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