美国国家药品编码应用简介

doi:10.5246/jcps.2019.03.020

中国药学(英文版) ›› 2019, Vol. 28 ›› Issue (3): 203-208.DOI: 10.5246/jcps.2019.03.020

• 【药事管理与临床药学专栏】 • 上一篇下一篇

美国国家药品编码应用简介

杨东升, 马玲云, 牛剑钊, 许鸣镝^*

中国食品药品检定研究院, 北京 100050

收稿日期:2019-01-15 修回日期:2019-02-27 出版日期:2019-03-30 发布日期:2019-02-28
通讯作者: Tel.: +86-13521033996, E-mail: yangdongsheng@nifdc.org.cn
基金资助:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

Brief introduction for application of the USA national drug code

Dongsheng Yang, Lingyun Ma, Jianzhao Niu, Mingdi Xu^*

National Institutes for Food and Drug Control, Beijing 100050, China

Received:2019-01-15 Revised:2019-02-27 Online:2019-03-30 Published:2019-02-28
Contact: Tel.: +86-13521033996, E-mail: yangdongsheng@nifdc.org.cn
Supported by:
National Science and Technology Major Projects for ‘Major New Drugs Innovation and Development’ (Grant No. 2017ZX09101001, Beijing, China).

摘要/Abstract

摘要：

美国橙皮书收录的参比制剂是我国仿制药参比制剂的一个重要来源, 因此其可及性对企业顺利开展仿制药一致性评价和仿制药研究工作具有重要意义。美国国家药品编码是每个药品独特的, 3段式的数字形式编号, 为该药品的通用标识号, 国家药品编码目录则收载了进入商品流通领域的所有处方药和非处方药的信息。本文系统阐述了国家药品编码的组成形式及其目录的来源, 发展概况和相关保障措施。同时, 以我国仿制药参比制剂目录(第一批)收录的源于美国橙皮书的参比制剂为例, 介绍了国家药品编码目录在参比制剂可及性方面的应用, 可有助于国内外制药企业查询、辨别和购买源自美国橙皮书的参比制剂, 也为药品监管机构筹备仿制药参比制剂目录提供参考。

关键词: 国家药品编码, 参比制剂, 仿制药质量与疗效一致性评价, 橙皮书

Abstract:

The reference listed drug (RLD) adopted in the USA orange book is the important source of the Chinese comparator product directories of generic medicinal products. Therefore, its availability has the vital significance for pharmaceutical enterprise to carry out the re-evaluation of generic medicinal products and study of generic medicinal products. The national drug code (NDC) is the unique, 3-segment number for each drug product in USA, and it serves as a universal product identifier for drugs. While the NDC directory adopts the information of drug products in the current commercial distribution, including all of the prescription drug and over the counter (OTC) drug products. The composition and configuration of the NDC number are systemically elaborated in this paper, as well as the data source, development history and supporting measures of the NDC directory. At the same time, by taking drugs, which are adopted in the Chinese comparator product directory of generic medicinal product (first batch) and sourced from USA orange book, as example, it introduces the application of the NDC directory in the availability aspect of the Chinese comparator products to facilitate the Chinese or foreign pharmaceutical manufacturers to search, identify and purchase the suitable RLD sourced from USA orange book. Moreover, it can provide reference for Chinese drug regulatory to prepare the Chinese comparator product directories of generic medicinal products.

Key words: National drug code, Comparator product, Re-evaluation of generic medicinal product, Orange book

中图分类号:

R951

Supporting:

杨东升, 马玲云, 牛剑钊, 许鸣镝. 美国国家药品编码应用简介[J]. 中国药学(英文版), 2019, 28(3): 203-208.

Dongsheng Yang, Lingyun Ma, Jianzhao Niu, Mingdi Xu. Brief introduction for application of the USA national drug code[J]. Journal of Chinese Pharmaceutical Sciences, 2019, 28(3): 203-208.

参考文献

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美国国家药品编码应用简介

Brief introduction for application of the USA national drug code

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