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欧盟仿制药参比制剂检索示例
欧盟仿制药参比制剂检索示例
许鸣镝,牛剑钊,杨东升,李 涛,乔利涛,高恬恬

中国食品药品检定研究院,北京 100050
An example for retriving reference medicinal products for marketing authorisation application of generic medicinal products in the EU
(National Institutes for Food and Drug Control,Beijing 100050,China)

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起始页:26

摘要:[摘要] 欧盟是由多个成员国组成的联盟,其药品的上市可以选择不同的申报途径和审评程序,所以目前并没有一个统一的囊括所有已在欧盟范围内上市的药品目录。为了便于查找和确认欧盟仿制药参比制剂,本文列表汇总了欧盟以及各成员国药品监管当局的网站和联系方式,并结合3种欧盟已上市药品的目录及其检索方法,如联盟注册目录、互认审评程序产品目录以及欧盟成员国产品目录,以检索仿制药米非司酮片(200 mg)在欧盟上市申请时须选用的参比制剂为例,详细介绍了如何检索和确定欧盟仿制药的参比制剂。

关键词:[关键词] 欧盟;参比制剂;欧洲药品管理局;人用药品互认和非集中审评程序协调组;米非司酮片

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Abstract:[Abstract] The European Union (EU) is a unique alliance composed of multiple member states, and diverse routes can be used for the marketing application of medicinal products, thus there is no comprehensive medicinal product list at present to include the entire marketed medicinal products in the EU. To facilitate the searching and identification of reference medicinal products used in supporting a marketing authorisation application in the EU, the websites and contact information of the drug regulatory authorities for the EU and its member states were summarized in a table. And by taking the mifepristone tablets (200 mg) as example, the searching and identification of its reference medicinal product used in supporting a marketing authorisation application in the EU was illustrated with the combination search in three marketed medicinal product lists, such as Community Register, MRI Product Index and Approved Drug Products list in each member state of the European Union.

Key words:[Key words] European Union; reference medicinal product; European Medicines Agency; co-ordination group for mutual recognition and decentralised procedures of drugs for human use; mifepristone tablet