美国药品参比制剂信息变更示例解析  

Analysis of one example of information change for reference listed drugs in USA

作　　者：杨东升 马玲云[1] 南楠[1] 牛剑钊[1] 许鸣镝[1] YANG Dong-sheng;MA Ling-yun;NAN Nan;NIU Jian-zhao;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

出　　处：《中国新药杂志》2019年第16期2015-2018,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:药物一致性评价关键技术与标准研究(2017ZX09101001)

摘　　要：参比制剂(reference listed drug,RLD)是用于仿制药质量和疗效一致性评价的对照药品。根据相关指南,是在欧盟、美国、日本获准上市并获得参比制剂地位的药品,也是我国仿制药参比制剂目录的重要来源。基于各种法规因素和商业因素,参比制剂的信息可能发生变化。本文以源自美国橙皮书的盐酸替扎尼定片4 mg(商品名:Zanaflex)为例,结合橙皮书目录、国家药品编码(national drug code,NDC)目录、“Drugs@FDA:FDA批准的药品数据库”和DailyMed产品标签库的支持数据,详细解析了其持证商(marketing authorization holder,MAH)信息变更的情况。在仿制药的研究开发和技术审评过程中,当参比制剂信息与官方公布信息有偏差时,本文内容可供参考。同时,建议对仿制药参比制剂目录进行动态管理、及时更新,促进一致性评价工作的顺利开展。Reference listed drugs ( RLDs) are used as comparator drugs in the re-evaluation of generic drug products. According to relevant guidelines,drugs that are approved to be listed in the European Union,the United States and Japan and have the status of RLDs are also important sources of Chinese reference listed drug directory of generic drug products. Information on RLDs may change based on various regulatory and commercial factors. In this paper,the tizanidine hydrochloride tablets 4 mg ( trade name: Zanaflex) from the USA orange book is taken as an example. Combined with the supporting data from the USA orange book,national drug code ( NDC) directory,“Drug@ FDA: FDA approved drug database”and DailyMed product label archives,the change of marketing authorization holder ( MAH) information was analyzed in detail. During the research and development as well as technical evaluation process of generic drugs,this paper can provide a reference in case where a deviation exists between the RLD information and the official information. At the same time,it is suggested to carry out dynamic management of Chinese RLD directory of generic drug products and update it timely to promote the smooth progress of re-evaluation.

关 键 词：参比制剂 国家药品编码 橙皮书 盐酸替扎尼定片 FDA 

分 类 号：R95[医药卫生—药学]