中国食品药品监管Issue(2)：50-61,12.DOI:10.3969/j.issn.1673-5390.2025.02.005
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
谢金平 1黄淼 1朱梦雅 1陈怡 1邵蓉1
作者信息
摘要
Abstract
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Key words
3D printing/3D-printed drugs/drug development and marketing/regulatory science/policy分类
医药卫生引用本文复制引用
谢金平,黄淼,朱梦雅,陈怡,邵蓉..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[J].中国食品药品监管,2025,(2):50-61,12.
