国内外细胞和基因治疗药品监管研究

Regulation of cellular and gene therapies at home and abroad

目的 为完善我国细胞和基因治疗药品监管,促进产业高质量发展提供建议。方法 通过查阅法规和文献,对比分析美、欧、日国家或地区细胞和基因治疗产品监管基本情况,结合我国监管实际情况和产业发展需求,分析国外监管模式给予我国的启示。结果和结论 基于目前我国细胞和基因治疗药品审评审批的具体实际,借鉴美日欧监管模式和审评流程设计,从创新监管理念、整合审评资源、加强国际交流与合作以及加大扶持力度等方面着手推进我国监管体系的发展。

Objective To give tips about how to improve the regulation of cellular and gene therapies in China and promote high-quality development of the industry.Methods The ways in which cellular and gene therapy products were regulated in the US,Japan and Europe were compared by reviewing regulations and literature.The implications for China were analyzed in the light of actual regulation in China and the needs of industrial development.Results and Conclusion Based on the current practices related to the review and approval of cellular and gene therapies in China and by learning from the regulatory models and review process designs of the United States,Japan and Europe,China’s regulatory system can be upgraded by means of innovative regulatory concepts,integration of review resources,more international exchanges and cooperation as well as intensified efforts.