摘要
本文聚焦以药为主的药械组合产品的监管策略,对比分析美国、欧盟、日本、加拿大、中国关于药械组合产品的定义、范围和管理模式;梳理总结了美国食品药品监督管理局(Food and Drug Administration,FDA)近5年科技报告个药指南中的药械组合产品类型以及中国2017年2月—2023年3月间公布的药械组合产品属性界定结果,提出了中国药械组合产品发展存在的问题及解决建议,以提高国内药械组合产品分类界定的一致性、可预测性和透明度,为该类产品的发展及科学监管提供参考。
This paper focuses on the regulatory strategy of drug-led drug device combination products,comparing and analyzing the definition,scope and management mode of drug device combination products in the United States,the European Union,Japan,Canada and China;summarizing and analyzing the types of combination products in the Product-specific Guidances for Generic Drug Development(PSGs)of the US FDA’s scientific and technical reports in the past five years,the results show that the top three PSGs newly added to the FDA were transdermal system,nasal sprays,and single-dose prefilled syringes/pens(including auto-injectors).As of March 1,2023,the National Medical Products Administration(NMPA)had cumulatively announced the results of 339 combination products applied for attribute definition by enterprises,of which 88 were“drug-led drug device combination products”,accounting for 26%;and 78 were“device-led drug device combination products”,accounting for 23%;the results of“not belonging to drug device combination products”accounted for more than half(51.0%),which indicated that there was a big difference between the industry and the regulatory understanding of the definition of drug-device combination products,and that the existing guideline and documents were unable to provide clear and predictable positioning of the combination products under research and development for the time being.This paper also puts forward suggestions for solving the problems in the development of drug-device combination products in China,in order to improve the consistency,predictability and transparency of the classification and definition of drug-device combination products in China,and to provide references for the development and scientific supervision of this kind of products.
作者
葛渊源
廖萍
贾国舒
梁艳
张景辰
陈桂良
袁红梅
GE Yuanyuan;LIAO Ping;JIA Guoshu;LIANG Yan;ZHANG Jingchen;CHEN Guiliang;YUAN Hongmei(Shenyang Pharmaceutical University,Shenyang 110016,China;Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China;China Pharmaceutical University,Nanjing 211198,China;Center for Inspection of Gansu(Center for Vaccine Inspection of Gansu),Lanzhou 730030,China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2023年第20期2774-2785,共12页
Chinese Journal of Modern Applied Pharmacy
基金
上海市市场监督管理局立项课题(20230233)
上海市药监局立项课题(LX-2023-04)。
关键词
药械组合
以药为主
属性界定
监管科学
combination products
drug-led
attribute definition
regulatory science
