中国食品药品监管Issue(5)：52-63,12.DOI:10.3969/j.issn.1673-5390.2024.05.006
以药品作用为主的药械组合产品注册法规体系的思考和建议
Considerations and Suggestions on the Regulation System for Registration of Drug-led Drug-Device Combination Products
李流兵 1汪施若 2赵岩松 3张永妍 3吴正宇 4忻之铖 5王俊杰 6赵忠斌 7刘翠萍 8孟婷婷 9田亮10
作者信息
- 1. 阿斯利康全球研发(中国)有限公司
- 2. 勃林格殷格翰(中国)投资有限公司
- 3. 罗氏(中国)投资有限公司
- 4. 诺和诺德(上海)医药贸易有限公司
- 5. 卫材(中国)药业有限公司
- 6. 默克雪兰诺(北京)医药研发有限公司
- 7. 安进生物医药(上海)有限公司
- 8. 强生(中国)投资有限公司
- 9. 百时美施贵宝(中国)投资有限公司
- 10. 先声再明医药有限公司
- 折叠
摘要
Abstract
This article summarizes and compares the definitions,regulatory agencies,review mechanisms,and relevant regulations of drug-led drug-device combination products among China,the United States,the European Union and Japan.It also addresses issues encountered during the R&D and registration process of such combination products in China.Feasible suggestions are provided on communication between applicants and regulatory authorities,attribute definition of drug-device combination products,technical requirements for registration applications,and coordination mechanism of the joint review between the Center for Drug Evaluation(CDE)and the Center for Medical Device Evaluation(CMDE).The aim is to provide references for promoting the development of the regulatory systems for drug-led drug-device combination products in China.关键词
药械组合产品/注册法规/非单一实体/组合包装/标签交叉引用Key words
drug-device combination products/registration regulations/non-single entity/co-package/cross-labeling分类
医药卫生引用本文复制引用
李流兵,汪施若,赵岩松,张永妍,吴正宇,忻之铖,王俊杰,赵忠斌,刘翠萍,孟婷婷,田亮..以药品作用为主的药械组合产品注册法规体系的思考和建议[J].中国食品药品监管,2024,(5):52-63,12.
