以药为主的药械组合产品监管发展现状与思考

葛渊源; 廖萍; 贾国舒; 梁艳; 张景辰; 陈桂良; 袁红梅<sup>*</sup>

引用本文:	葛渊源,廖萍,贾国舒,梁艳,张景辰,陈桂良,袁红梅.以药为主的药械组合产品监管发展现状与思考[J].中国现代应用药学,2023,40(20):2774-2785.
	GE Yuanyuan,LIAO Ping,JIA Guoshu,LIANG Yan,ZHANG Jingchen,CHEN Guiliang,YUAN Hongmei.Current Status and Regulatory Considerations of Drug-led Combination Products[J].Chin J Mod Appl Pharm(中国现代应用药学),2023,40(20):2774-2785.

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以药为主的药械组合产品监管发展现状与思考
葛渊源^1,2, 廖萍², 贾国舒³, 梁艳⁴, 张景辰², 陈桂良², 袁红梅¹
1.沈阳药科大学, 沈阳 110016;2.上海药品审评核查中心, 上海 201203;3.中国药科大学, 南京 211198;4.甘肃省药品监督管理局审核查验中心(甘肃省疫苗检查中心), 兰州 730030

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。

关键词: 药械组合以药为主属性界定监管科学

DOI：10.13748/j.cnki.issn1007-7693.20231864

分类号:R951

基金项目: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）

Current Status and Regulatory Considerations of Drug-led Combination Products

GE Yuanyuan^1,2, LIAO Ping², JIA Guoshu³, LIANG Yan⁴, ZHANG Jingchen², CHEN Guiliang², YUAN Hongmei¹

1.Shenyang Pharmaceutical University, Shenyang 110016, China;2.Shanghai Center for Drug Evaluation and Inspection, Shanghai 201203, China;3.China Pharmaceutical University, Nanjing 211198, China;4.Center for Inspection of Gansu (Center for Vaccine Inspection of Gansu), Lanzhou 730030, China

Abstract:

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.

Key words: combination products drug-led attribute definition regulatory science