红霉素肠溶胶囊在欧盟和美国参比制剂的调研介绍  

Investigation of reference listed drug for erythromycin enteric-coated capsule in EU and USA

作　　者：牛剑钊[1] 杨东升 马玲云[1] 许鸣镝[1] NIU Jian-zhao;YANG Dong-sheng;MA Ling-yun;XU Ming-di(National Institutes for Food and Drug Control,Beijing 100050,China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国新药杂志》2020年第19期2190-2193,共4页Chinese Journal of New Drugs

基　　金：国家“重大新药创制”科技重大专项资助项目(2017ZX09101001):药物一致性评价关键技术与标准研究。

摘　　要：参比制剂是顺利开展仿制药质量和疗效一致性评价以及仿制药品研发和审评的重要前提。随着我国仿制药一致性评价工作的逐步推进和展开,参比制剂遴选与确定的程序也日益完善,但存在的各种问题也逐渐展现出来。由于各种原因,一些仿制药品的参比制剂难以确定,或者参比制剂虽可确定,但在市场上却难以获得。同时,缓控释制剂的质量和疗效受产品处方工艺的影响较大,可能涉及不同的释放机制及处方工艺,制药企业在仿制药开发过程前应确认已公布的参比制剂是否适用于本企业产品;如不适用,应另行备案。本文以红霉素肠溶胶囊为例,介绍了其在欧盟和美国仿制药参比制剂的检索过程,希望为制药界的研究人员在参比制剂选择遇到困难时,提供一种解决问题的思路和途径。The reference listed drug is an important prerequisite for consistency evaluation of the quality and efficacy of generic medicinal product,as well as its R&D and evaluation.With the progress and development of the consistency evaluation of the generic medicinal product in China,the selection and determination procedures of reference listed drug are becoming more and more developed;however,the existing problems gradually revealed as well.For a variety of reasons,the reference listed drugs for some medicinal products are difficult to select,or although the reference listed drug can be decided,it is unavailable from the market.At the same time,the quality and efficacy of sustained-release or control-release drug products are greatly affected by the product formulation and technology,which may involve different release mechanisms and formulation processes.Pharmaceutical enterprise should confirm whether the published reference listed drug is applicable to his generic medicinal product before the beginning of the work.If not,it should be filed separately.Taking Erythromycin Enteric-coated Capsule as an example,the retrieval process of reference listed drug for generic medicinal product from the in EU and USA was introduced in this paper,and we hope to provide a thought and strategy to solve the problem when the researchers in the pharmaceutical industry encounter difficulties in choosing reference listed drug.

关 键 词：参比制剂 红霉素肠溶胶囊 仿制药质量和疗效一致性评价 美国食品药品监督管理局 欧洲药品管理局 

分 类 号：R95[医药卫生—药学]