国家基本药物目录视角下的过评仿制药分析
Analysis of evaluated generic drugs from the perspective of the National Essential Medicine List
王金石 1赵紫楠 2李可欣 3张天齐 2朱柏霖 2纪立伟 2金鹏飞 2胡欣 2罗小峰 1赵飞2
作者信息
- 1. 兰州大学 公共卫生学院,兰州 730000
- 2. 北京医院 药学部,北京 100730
- 3. 北京医院 临床试验研究中心,国家老年医学中心 中国医学科学院老年医学研究院 药物临床风险与个体化应用评价北京市重点实验室,北京 100730
- 折叠
摘要
目的 探讨我国基本药物过评仿制药情况和重复仿制现状.方法 搜集、整理国家药品监督管理局2017年8月1日至2023年9月1日公布的通过一致性评价的仿制药产品信息,统计分析过评仿制药的重复情况及其在2018年版《国家基本药物目录》中的分布与变化情况.结果 共收集到来自不同厂家的7431个仿制药产品,2818个品规,1170个品种,涉及26种药理作用类别和41种剂型.438种基本药物中,135(30.8%)种全部品规有过评仿制药,104(23.7%)种部分品规有过评仿制药,199(45.4%)种品规无过评仿制药.基本药物共计1128个品规,614(54.4%)个品规无过评仿制药,514(45.6%)个品规有过评仿制药.326(63.4%)个品规的基本药物过评仿制药重复产品数为1～3个,79(15.4%)个品规的基本药物过评仿制药重复产品数为4～6个,109(21.2%)个品规的基本药物过评仿制药重复产品数≥7个.结论 我国基本药物的仿制尚不均衡,部分基本药物过评仿制药过度重复仿制现象严重.
Abstract
Objective To explore the situation of generic drugs that have undergone consistency evaluation within Chi-na's Essential Medicines and the prevalence of excessive replication among these generics.Methods Data on generic drugs that passed the consistency evaluation from August 1 2017 to September 1 2023 was collected from the National Medical Prod-ucts Administration.This data was analyzed to assess the excessive replication of these generics and examine their distribution and changes within the 2018 version of the National Essential Medicines List.Results A total of 7431 generic drug products from various manufacturers were collected,comprising 2818 specifications and 1170 varieties across 26 pharmacological cate-gories and 41 dosage forms.Of the 438 essential medicines,135(30.8%)had all specifications represented by evaluated ge-nerics,104(23.7%)had some,and 199(45.4%)had none.Of these,1128 specifications were analyzed,614(54.4%)of which had no evaluated generics,while 514(45.6%)did.Furthermore,326(63.4%)specifications had 1 to 3 redundant evaluated products,79(15.4%)had 4 to 6,and 109(21.2%)had seven or more.Conclusion The production of generics within China's Essential Medicines List shows significant unevenness,particularly in the excessive replication of evaluated ge-nerics in some essential medicines.
关键词
国家基本药物目录/仿制药/一致性评价/重复仿制Key words
National Essential Drugs List/generic drugs/consistency evaluation/duplicate引用本文复制引用
基金项目
国家卫生健康委医院管理研究所医院药学高质量发展研究项目(NIHAYS2332)
北京市科技计划(Z191100007619038)
出版年
2024
NETL
NSTL
万方数据