监管科学视角下增材制造(3D打印)药物研发上市关键问题及监管政策研究  

Research on Key Issues and Regulatory Policies for the Development and Marketing of 3D-Printed Drugs from the Perspective of Regulatory Science

作　　者：谢金平 黄淼 朱梦雅 陈怡[1] 邵蓉[1] XIE Jin-ping;HUANG Miao;ZHU Meng-ya;CHEN Yi;SHAO Rong(Institute of Regulatory Science for Medical Products,China Pharmaceutical University)

机构地区：[1]中国药科大学药品监管科学研究院

出　　处：《中国食品药品监管》2025年第2期50-61,共12页China Food & Drug Administration Magazine

摘　　要：随着现代生物医药新技术、新方法的飞速发展,增材制造(3D打印)技术已应用于药物及医疗器械的开发和制造中,并凭借着高度的灵活性和广阔的应用前景受到制药企业的广泛关注。本研究系统梳理了3D打印技术及其在制药领域的应用、相关政策以及3D打印药物研发上市进展等,并结合访谈调研,从监管科学视角提出3D打印药物研发上市的可能关注点,以期为3D打印药物研发上市、惠及患者提前做好监管政策储备。With the rapid development of new technologies and methods in modern biomedicine,3D printing technology has been applied to the development and manufacturing of drugs and medical devices.Its high degree of flexibility and broad application prospects have attracted significant attention from pharmaceutical companies.This study systematically reviews 3D printing technology and its application in the pharmaceutical field,relevant policies,and the progress of 3D-printed drug development and marketing.Based on interviews and surveys,the paper identifies potential concerns for the R&D and marketing of 3D-printed drugs from a regulatory science perspective,so as to establish a policy framework that can support the development and marketing of these products and ultimately benefit patients.

关 键 词：3D打印 3D打印药物 研发上市 监管科学 政策 

分 类 号：R95[医药卫生—药学]