韩国细胞治疗产品监管政策及对我国的启示

Regulations of cell therapy products in Korea and the enlightenment to China

随着生物治疗产业的蓬勃发展,有关细胞治疗的创新性技术、应用和成果不断涌现,在多个医学领域显示出应用潜力,我国也在逐渐增加细胞治疗临床研究,科学的监管体系是推进其产业化发展的重要一环。我国制定了一系列相关监督政策和指导意见,然而针对细胞治疗产业化的监管体系还未完全建立,按药品申报进行上市的审批路径还未明晰。本文对韩国细胞治疗产品在开发、审批和上市阶段的监管体系进行梳理,对监管特点进行总结,以期为我国细胞治疗产品监管体系的完善提出建议。

With the booming development of biological therapy industry,innovative technologies,applications and achievements related to cell therapy keep emerging and show the application potential in many medical fields.The clinical research of cell therapy is also gradually increasing in China,and scientific regulatory system become an important part to promote its industrial development. China has formulated a series of relevant supervision policies and guidelines,but the regulatory system for the industrialization of cell therapy has not been fully established yet,and the approval path for listing according to drug declaration has not been made clear. This review combs the regulatory system of Korean cell therapy products in the development,approval and marketing stages,summarizes the regulatory characteristics,and puts forward the suggestions on improving the regulatory system of cell therapy products in China.